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A Clinical Trial to Assess Safety and Pharmacokinetics of Fosnetupitant 235 mg and Metabolites in Healthy Volunteers

NCT06840769 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-04

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

DRUG

Akynzeo solution

235 mg fosnetupitant (corresponding to 260 mg of the chloride hydrochloride salt) / 0.25 mg palonosetron in 20 mL injectable solution

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Milko Radicioni · Cross Research S.A.

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-17
Primary Completion
2023-10-18
Completion
2023-10-23
FDA Drug
Yes

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840769 on ClinicalTrials.gov