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

NCT04962724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-12-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Debiopharm International SA

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2021-11-09
Completion
2021-11-09

Countries

  • United Kingdom

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 NCT04962724 on ClinicalTrials.gov