NCT04962724

A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants

A Phase 1, Open-label, 2-part, Single-dose Study of the Absorption, Metabolism, and Excretion of Oral [14C]-Xevinapant, and Absolute Oral Bioavailability of Xevinapant in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine absorption, metabolism, and excretion of a single oral dose of \[14C\]-xevinapant. This information will enable assessment of absorption and clearance mechanisms of \[14C\]-xevinapant as well as identify metabolites. In addition, the study will allow to determine absolute bioavailability of xevinapant and understand its intravenous pharmacokinetics.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Radiolabelled Xevinapant 200 mg (Oral Solution)	\[14C\]-Xevinapant 200 mg administered as an oral solution on Day 1 of Part 1, containing approximately 100 microcurie (μCi) \[3.7 megabecquerel (MBq)\] in fasted conditions.
DRUG	Radiolabelled Xevinapant 100 μg (IV Solution)	100 μg \[14C\]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi \[7.4 kilobecquerel (kBq)\].
DRUG	Xevinapant 200 mg (Oral Solution)	Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions

Timeline

• Start date: 2021-08-02
• Primary completion: 2021-11-09
• Completion: 2021-11-09
• First posted: 2021-07-15
• Last updated: 2021-12-27

Locations

1 site across 1 country: United Kingdom