Terminated
`Sponsor's decision
`A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235
`mg and Metabolites in Healthy Volunteers
`ClinicalTrials.gov ID NCT06840769
`Sponsor Helsinn Healthcare SA
`Information provided by Helsinn Healthcare SA (Responsible Party)
`Last Update Posted 2025-05-04
`Study Details Tab
`Study Overview
`Brief Summary
`This clinical trial will include two parts, i.e., Part A and Part B.
`The goal of the Part A is to define the shortest safe and tolerable duration of an intravenous injection of
`Fosnetupitant 235 mg solution among 4 durations tested in male and female adult healthy volunteers.
`In study part A, researchers will compare Fosnetupitant 235 mg solution to Akynzeo® solution.
`The duration determined in Part A will be investigated in study Part B.
`The Part B of the study was not performed.
`The U.S. government does not review or approve the safety and science of all studies
`listed on this website.
`Read our full disclaimer(https://clinicaltrials.gov/about-site/disclaimer) for details.
`Detailed Description
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
`https://clinicaltrials.gov/study/NCT06840769 1/29
`HELSINN EXHIBIT 2027
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00945
`Page 1 of 29
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`The registered product Akynzeo® (235 mg fosnetupitant/0.25 mg palonosetron) solution for
`intravenous injection, used before chemotherapy, is to be diluted up to a final volume of 50 mL and
`administered during 30 min infusion. With the aim to facilitate and improve the use of this kind of
`products, the Sponsor Helsinn focused on the development of a ready to use solution, not requiring
`additional dilutions, and to be administered as a bolus injection. The product developed by Helsinn is a
`liquid formulation for infusion, containing exclusively fosnetupitant 235 mg free base.
`Aim of the present open label, single dose, two parts (part A and part B) phase I study is to evaluate the
`safety and the pharmacokinetic profile of this new product, i.e., Fosnetupitant 235 mg ready to use
`solution for intravenous injection. In addition, the pharmacokinetic profile of fosnetupitant, netupitant
`(fosnetupitant is rapidly converted in netupitant after intravenous administration) and netupitant
`metabolites (M1, M2 and M3) will be investigated after a 30-min infusion of the registered Akynzeo®
`liquid formulation.
`Part A of the study:
`In cohort 1, 10 healthy volunteers will receive a dose of Fosnetupitant 235 mg solution as a one single
`30-min intravenous infusion and additional 10 subjects will receive a single intravenous dose of
`Akynzeo® solution as a one single 30-min intravenous infusion, according to a parallel group design.
`In each of 3 consecutive cohorts (cohorts 2, 3 and 4), 10 healthy volunteers will receive a single
`intravenous dose of Fosnetupitant 235 mg solution at a predefined infusion duration and will be
`sequentially treated as 3 subgroups of 3, 3, and 4 subjects, respectively.
`A staggered approach with decreasing infusion time duration will be applied, from cohort 1 to cohort 4,
`to the administration of Fosnetupitant free base 235 mg solution, as follows:
`Cohort 1: 30 min Cohort 2: 15 min Cohort 3: 5 min Cohort 4: 2 min
`At the end of cohort 1 and of each subgroup of cohorts 2, 3 and 4, safety and tolerability results will be
`evaluated by the Investigator and the study Sponsor Medical Expert. Predefined stopping rules will be
`considered for deciding about continuing with the next cohort treatment and a shorter injection
`duration of Fosnetupitant 235 mg solution. Specifically, after cohort 1, if the injection duration of 30 min
`proves to be safe and well tolerated, 15 min injection duration will be tested in cohort 2. If the injection
`duration of 15 min proves to be safe and well-tolerated, 5 min injection duration will be tested in cohort
`3. If the injection duration of 5 min proves to be safe and well tolerated, a 2 min injection will be tested
`in cohort 4.
`The selected shortest (safe and tolerable) injection duration determined in Part A will be investigated in
`study Part B.
`The study was prematurely terminated after the end of Part A and study Part B was not performed.
`Official Title
`A Phase I, Open Label, Single Dose, Two Parts Study in Male and Female Healthy Subjects to Assess
`the Safety and Pharmacokinetics of Fosnetupitant 235 mg Administered as IV Bolus and of Derived
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`Netupitant and Netupitant Metabolites
`Conditions
`Healthy Volunteers
`Intervention / Treatment
`Drug: Fosnetupitant 235 mg solution
`Drug: Akynzeo solution
`Other Study ID Numbers
`Study Start (Actual)
`2023-06-17
`Primary Completion (Actual)
`2023-10-18
`Study Completion (Actual)
`2023-10-23
`Enrollment (Actual)
`50
`Study Type
`Interventional
`Phase
`Phase 1
`Resource links provided by the National Library of Medicine
`FDA Drug and Device Resources(https://clinicaltrials.gov/fda-links)
`Contacts and Locations
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`This section provides contact details for people who can answer questions about joining this study, and
`information on where this study is taking place.
`To learn more, please see the Contacts and Locations section in How to Read a Study
`Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).
`This study has 1 location
`Switzerland
`Canton Ticino Locations
`Arzo, Canton Ticino, Switzerland, CH-6864
`CROSS Research S.A.
`Participation Criteria
`Researchers look for people who fit a certain description, called eligibility criteria. Some examples of
`these criteria are a person's general health condition or prior treatments.
`For general information about clinical research, read Learn About
`Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
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`Eligibility Criteria
`Description
`Inclusion criteria
`1. Informed consent: signed written informed consent before inclusion in the study
`2. Sex and Age: healthy men/women volunteers, 18-55 years old (inclusive)
`3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
`4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg,
`pulse rate 50-99 bpm, measured after 5 min at rest in the sitting position
`5. Full comprehension: ability to comprehend the full nature and purpose of the study,
`including possible risks and side effects; ability to co-operate with the investigator and to
`comply with the requirements of the entire study
`6. Contraception and fertility (women only): women of childbearing potential defined as a non-
`menopausal woman who has not had a bilateral oophorectomy or medically documented
`ovarian failure and/or at risk for pregnancy must agree, signing the informed consent form,
`to use a highly effective method of contraception throughout the study and to continue for
`14 days after the last dose of the study treatment. Highly effective contraceptive measures
`include:
`1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2
`months before the screening visit.
`2. A non-hormonal intrauterine device [IUD] for at least 2 months before the screening
`visit
`3. A sterile or vasectomized sexual partner
`4. True (long-term) heterosexual abstinence, defined as refraining from heterosexual
`intercourse when this is in line with the preferred and usual lifestyle of the subject,
`while periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
`methods), lactational amenorrhea and withdrawal are not acceptable.
`Women of non-child-bearing potential or in post-menopausal status defined as such when
`there is either:
`1. 12 months of spontaneous amenorrhea or
`2. 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or
`3. 6 weeks documented postsurgical bilateral oophorectomy with or without
`hysterectomy will be admitted. For all women, pregnancy test result must be negative
`at screening and admission (Day -1).
`7. Contraception (men only): men will either be sterile or agree to use one of the following
`approved methods of contraception from the first study drug administration until at least 14
`days after the last administration, also in case their partner is currently pregnant:
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`1. A male condom with spermicide
`2. A sterile sexual partner or a partner in post-menopausal status for at least one year
`3. Use by the female sexual partner of an IUD, a female condom with spermicide, a
`contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap
`with spermicide, or hormonal oral, implantable, transdermal, or injectable
`contraceptives for at least 2 months before the screening visit Men must accept to
`inform their partners of the participation in the clinical study. Furthermore, they will
`not donate sperm from the date of the informed consent form's signature, throughout
`the study, and for at least 14 days after the last dose of the study treatment. These
`requirements are based upon the availability and results of reproductive toxicity data.
`Exclusion criteria
`1. 12-leads Electrocardiogram (ECG) (supine position): clinically significant abnormalities at
`screening. With regards to QTc, the following will be considered as exclusion criterion:
`mean corrected QT (QTcF) > 450 ms. HR < 50 or > 99 bpm. PR < 100 or >220 ms. QRS > 120
`ms. Relevantly abnormal T-wave patterns
`2. Physical examination findings: clinically significant abnormal physical findings which could
`interfere with the objectives of the study
`3. Laboratory analyses: clinically significant abnormal laboratory values at screening,
`indicative of physical illness or suggesting the subject's exclusion, in his/her best interest
`4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or
`formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general,
`which the investigator considers may affect the outcome of the study
`5. Diseases: significant history, in the opinion of the Investigator, of renal, hepatic,
`gastrointestinal, cardiovascular (in particular, heart failure, hypokalemia, family history of
`Long QT Syndrome, history of superficial thrombophlebitis or deep vein thrombosis),
`respiratory, skin, hematological, endocrine or neurological diseases that may interfere with
`the aim of the study
`6. Medications: medications, including over the counter (OTC) medications and herbal
`remedies in the 2 weeks before the first visit of the study. Hormonal contraceptives for
`women are allowed
`7. CYP3A4 inducers and inhibitors: use of any inducer or inhibitor of CYP3A4 enzymes (drugs,
`food, herbal remedies) in the 28 days or in the 7 days, respectively, before the planned first
`study drug administration and during the whole study
`8. Investigative drug studies: participation in the evaluation of any investigational product for
`3 months before this study. The 3-month interval is calculated as the time between the first
`calendar day of the month that follows the last visit of the previous study and the first day
`of the present study
`9. Blood donation or significant blood loss: blood donations or significant blood loss in the 3
`months before the first visit of this study
`10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>1 drink/day for women and >2
`drinks/day for men, defined according to the USDA Dietary Guidelines 2020-2025 (11)],
`caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 cigarettes/day)
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`11. Drug test: positive result at the urine drug screening test at screening or Day -1
`12. Alcohol test: positive salivary alcohol test at Day -1
`13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in
`the 4 weeks before screening; vegetarians
`14. Pregnancy (women only): positive or missing pregnancy test at screening or Day -1,
`pregnant or lactating women
`15. Netupitant studies: enrolment in a previous study of netupitant or fosnetupitant (alone or in
`combination with palonosetron)
`Ages Eligible for Study
`18 Years to 55 Years (Adult)
`Sexes Eligible for Study
`All
`Accepts Healthy Volunteers
`Yes
`Study Plan
`This section provides details of the study plan, including how the study is designed and what the study
`is measuring.
`How is the study designed?
`Design Details
`Primary Purpose : Health Services Research
`Allocation : Non-Randomized
`Interventional Model : Sequential Assignment
`Interventional Model Description: Open label, single dose, two parts (part A and part B),
`safety and pharmacokinetic phase I study.
`Masking : None (Open Label)
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`Arms and Interventions
`Participant Group/ArmIntervention/Treatment
`Experimental: Study
`Part A - cohort 1
`Fosnetupitant free base
`235 mg administered as
`single 30 min
`intravenous infusion or
`235 mg
`fosnetupitant/0.25 mg
`palonosetron in 20 mL
`injection solution
`administered undiluted
`as a single 30 min
`intravenous infusion
`Drug: Fosnetupitant 235 mg solution
`Fosnetupitant free base 235 mg
`(corresponding to 260 mg of the chloride
`hydrochloride salt) in 20 mL ready to use
`injectable solution for intravenous
`administration
`Other Names:
`Helsinn Fosnetupitant solution
`Drug: Akynzeo solution
`235 mg fosnetupitant (corresponding to 260
`mg of the chloride hydrochloride salt) / 0.25
`mg palonosetron in 20 mL injectable solution
`Other Names:
`IV Akynzeo®
`Experimental: Study
`Part A - cohort 2
`Fosnetupitant free base
`235 mg administered as
`single 15 min
`intravenous infusion
`Drug: Fosnetupitant 235 mg solution
`Fosnetupitant free base 235 mg
`(corresponding to 260 mg of the chloride
`hydrochloride salt) in 20 mL ready to use
`injectable solution for intravenous
`administration
`Other Names:
`Helsinn Fosnetupitant solution
`Experimental: Study
`Part A - cohort 3
`Fosnetupitant free base
`235 mg administered as
`Drug: Fosnetupitant 235 mg solution
`Fosnetupitant free base 235 mg
`(corresponding to 260 mg of the chloride
`hydrochloride salt) in 20 mL ready to use
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`What is the study measuring?
`Primary Outcome Measures
`single 5 min
`intravenous infusion
`injectable solution for intravenous
`administration
`Other Names:
`Helsinn Fosnetupitant solution
`Experimental: Study
`Part A - cohort 4
`Fosnetupitant free base
`235 mg administered as
`single 2 min
`intravenous infusion
`Drug: Fosnetupitant 235 mg solution
`Fosnetupitant free base 235 mg
`(corresponding to 260 mg of the chloride
`hydrochloride salt) in 20 mL ready to use
`injectable solution for intravenous
`administration
`Other Names:
`Helsinn Fosnetupitant solution
`Outcome
`Measure Measure Description Time
`Frame
`Study Part A:
`Number of
`Treatment-
`emergent
`Adverse Events
`Number of treatment-emergent adverse events
`(TEAEs) collected up to 24 h post-dose.
`From
`screeni
`ng visit
`(day of
`informe
`d
`consent
`signatur
`e) up to
`24 h
`after
`the
`investig
`ational
`medicin
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`al
`product
`adminis
`tration
`(a
`maximu
`m of 21
`days)
`Study Part A:
`Number of
`Subjects With
`Treatment-
`emergent
`Adverse Events
`Number of subjects with treatment-emergent
`adverse events (TEAEs) collected up to 24 h
`post-dose.
`From
`screeni
`ng visit
`(day of
`informe
`d
`consent
`signatur
`e) up to
`24 h
`after
`the
`investig
`ational
`medicin
`al
`product
`adminis
`tration
`(a
`maximu
`m of 21
`days)
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`Secondary Outcome Measures
`Study Part A:
`Type of
`Treatment-
`emergent
`Adverse Events
`Type of treatment-emergent adverse events
`(TEAEs) collected up to 24 h post-dose.
`From
`screeni
`ng visit
`(day of
`informe
`d
`consent
`signatur
`e) up to
`24 h
`after
`the
`investig
`ational
`medicin
`al
`product
`adminis
`tration
`(a
`maximu
`m of 21
`days)
`Outcome
`Measure Measure Description Time
`Frame
`Study Part A:
`Systolic Blood
`Pressure
`Systolic blood pressure in mmHg measured
`after 5 min at rest in sitting position
`Screeni
`ng
`visit/da
`y -1
`(enrolm
`ent
`day)/da
`y 1
`(treatm
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`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`Diastolic Blood
`Pressure
`Diastolic blood pressure in mmHg measured
`after 5 min at rest in sitting position
`Screeni
`ng
`visit/da
`y -1
`(enrolm
`ent
`day)/da
`y 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
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`
`
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`Pulse Rate
`Pulse rate in bpm measured after 5 min at rest
`in sitting position
`Screeni
`ng
`visit/da
`y -1
`(enrolm
`ent
`day)/da
`y 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
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`
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`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`Weight
`Body weight in kilogramsScreeni
`ng visit
`(day of
`informe
`d
`consent
`signatur
`e)/final
`visit (7
`days
`after
`the
`treatme
`nt)
`Study Part A:
`Full Physical
`Examination
`Through
`Apparatus/Syst
`ems Check
`General appearance, Chest/respiratory,
`Gastrointestinal, Head, eyes, ears, nose and
`throat, Heart/cardiovascular, Lymph nodes,
`Metabolic/endocrine,
`Musculoskeletal/extremities, Neck (including
`thyroid), Neurological/psychiatric,
`Skin/dermatologic systems are checked. Any
`abnormalities are recorded.
`Screeni
`ng visit
`(day of
`informe
`d
`consent
`signatur
`e)/final
`visit (7
`days
`after
`the
`treatme
`nt)
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`Study Part A:
`Short Physical
`Examination
`Through
`Apparatus/Syst
`ems Check
`General appearance, Chest/respiratory,
`Heart/cardiovascular, Lymph nodes,
`Neurologic/psychiatric, Skin/dermatologic
`systems are checked. Any abnormalities are
`recorded.
`Day 2
`(24 h
`after
`the end
`of
`investig
`ational
`product
`adminis
`tration)
`Study Part A:
`ECGs - Heart
`Rate
`Heart rate in beats/min recorded in supine
`position after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
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`Study Part A:
`ECGs - PR
`Interval
`PR interval in ms recorded in supine position
`after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`ECGs - RR
`Interval
`RR interval in ms recorded in supine position
`after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
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`
`
`
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`ECGs - QRS
`Duration
`QRS duration in ms recorded in supine position
`after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
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`
`
`treatme
`nt)
`Study Part A:
`ECGs - QT
`Interval
`QT interval in ms recorded in supine position
`after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`ECGs - QTcB
`Interval
`QTcB interval in ms recorded in supine position
`after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
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`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`after
`the
`treatme
`nt)
`Study Part A:
`ECGs - QTcF
`Interval
`QTcF interval in ms recorded in supine position
`after 5 min at rest
`Screeni
`ng visit/
`day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at the
`end of
`adminis
`tration
`and 1,
`2, 4, 24
`h after
`the end
`of
`adminis
`tration/f
`inal visit
`(7 days
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`after
`the
`treatme
`nt)
`Study Part A:
`Clinical
`Laboratory
`Tests (Blood
`Chemistry,
`Haematology,
`Urinalysis)
`Leukocytes and leukocyte differential count,
`erythrocytes, haemoglobin, haematocrit, MCV,
`MCH, MCHC, thrombocytes, electrolytes
`(sodium, potassium, calcium, chloride,
`inorganic phosphorus), enzymes (alkaline
`phosphatase, γ-GT, AST, ALT),
`substrates/metabolites (total bilirubin,
`creatinine, glucose, urea, uric acid, total
`cholesterol, triglycerides), total proteins, urine
`chemical analysis (pH, specific weight,
`appearance, color, nitrites, proteins, glucose,
`urobilinogen, bilirubin, ketones, hematic
`pigments, leukocytes), urine sediment (analysis
`performed only if positive: leukocytes,
`erythrocytes, flat cells, round cells, crystals,
`cylinders, mucus, bacteria, glomerular
`erythrocytes). Any abnormalities are recorded.
`Screeni
`ng visit
`(day of
`informe
`d
`consent
`signatur
`e)/final
`visit (7
`days
`after
`the
`treatme
`nt)
`Study Part A:
`Cmax
`Maximum plasma concentration measured for
`plasma fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`
`after
`the
`adminis
`tration
`Study Part A:
`C0
`Plasma concentration at the end of the
`administration measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`Tmax
`Time to achieve the maximum plasma
`concentration measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`Clast
`Last measurable plasma concentration
`measured for plasma fosnetupitant, netupitant
`and its main metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`Tlast
`Time of last measurable plasma concentration
`measured for plasma fosnetupitant, netupitant
`and its main metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`AUC0-t
`Area under the concentration-time curve from
`time zero to time of last measurable plasma
`concentration measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`AUC0-24
`Area under the plasma concentration-time
`curve from time zero to 24 h after the
`administration measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3)
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`Terminal
`Elimination
`Rate Constant
`Terminal elimination rate constant, calculated,
`if feasible, by log-linear regression using at
`least 3 points, C0 and Cmax excluded and
`measured for plasma fosnetupitant, netupitant
`and its main metabolites (M1, M2 and M3).
`Calculation was not feasible for M1 and M3,
`therefore these analytes are not reported in the
`Outcome Measure Data Table.
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`t1/2
`Apparent terminal half-life calculated, if
`feasible, by as ln2/terminal elimination rate
`constant and measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3). Calculation was
`not feasible for M1 and M3, therefore these
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`Page 24 of 29
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`analytes are not reported in the Outcome
`Measure Data Table.
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`Systemic
`Clearance
`Systemic clearance measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3). Calculation was
`not feasible for M1 and M3, therefore these
`analytes are not reported in the Outcome
`Measure Data Table.
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`Vz
`Apparent volume of distribution in the post-
`distribution phase measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3). Calculation was
`not feasible for M1 and M3, therefore these
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`Page 25 of 29
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`analytes are not reported in the Outcome
`Measure Data Table.
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`Study Part A:
`MRT
`Mean residence time measured for plasma
`fosnetupitant, netupitant and its main
`metabolites (M1, M2 and M3). Calculation was
`not feasible for M1 and M3, therefore these
`analytes are not reported in the Outcome
`Measure Data Table.
`Day 1
`(treatm
`ent day)
`at pre-
`adminis
`tration,
`at 2, 5,
`10, 15,
`20, 30
`and 45
`min and
`at 1,
`1.5, 2, 3,
`4, 8, 12,
`24 h
`after
`the
`adminis
`tration
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`Collaborators and Investigators
`This is where you will find people and organizations involved with this study.
`Helsinn Healthcare SA
`Study Record Dates
`These dates track the progress of study record and summary results submissions to ClinicalTrials.gov.
`Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure
`they meet specific quality control standards before being posted on the public website.
`Study Registration Dates
`First Submitted
`2025-02-11
`First Submitted that Met QC Criteria
`2025-02-18
`First Posted
`2025-02-21
`Results Reporting Dates
`Results First Submitted
`2025-03-25
`Results First Submitted that Met QC Criteria
`2025-04-16
`Results First Posted
`2025-05-04
`Study Record Updates
`Last Update Submitted that met QC Criteria
`2025-04-16
`Sponsor
`Investigators
`Principal Investigator:Milko Radicioni,Cross Research S.A.
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`
`Last Update Posted
`2025-05-04
`Last Verified
`2025-04
`More Information
`Terms related to this study
`Plan for Individual Participant Data (IPD)
`Drug and device information, study documents, and helpful links
`HHS Vulnerability Disclosure
`Keywords Provided by Helsinn Healthcare SA
`Helsinn
`PNET-22-08
`Fosnetupitant
`Netupitant
`Additional Relevant MeSH Terms
`Pharmaceutical Solutions
`Plan to Share Individual Participant Data (IPD)?
`No
`IPD Plan Description
`No need to share IPD
`Studies a U.S. FDA-Regulated Drug Product
`Yes
`Studies a U.S. FDA-Regulated Device Product
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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`
`No
`Study Protocol(https://cdn.clinicaltrials.gov/large-docs/69/NCT06840769/Prot_000.pdf)
`[PDF, 1.3MB, 2023-05-24]
`Statistical Analysis Plan(https://cdn.clinicaltrials.gov/large-
`docs/69/NCT06840769/SAP_001.pdf) [PDF, 11.41MB, 2024-06-18]
`Study Documents Provided by Helsinn Healthcare SA
`8/3/25, 4:07 PM Study Details | A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteer…
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