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

NCT ID: NCT04962724

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-02

Study Completion Date

2021-11-09

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Xevinapant Absorption, Distribution, Metabolism and Excretion (ADME) Mass balance Absolute bioavailability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Radiolabeled Xevinapant Oral Solution

Participants will receive:

• single oral dose of \[14C\]-xevinapant, as an oral solution

Group Type EXPERIMENTAL

Radiolabelled Xevinapant 200 mg (Oral Solution)

Intervention Type DRUG

\[14C\]-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.

Radiolabeled Xevinapant Intravenous Solution + Xevinapant Oral Solution

Participants will receive:

• single oral dose of xevinapant, as an oral solution followed by an IV bolus of \[14C\]-xevinapant, solution for infusion

Group Type EXPERIMENTAL

Radiolabelled Xevinapant 100 μg (IV Solution)

Intervention Type DRUG

100 μg \[14C\]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi \[7.4 kilobecquerel (kBq)\].

Xevinapant 200 mg (Oral Solution)

Intervention Type DRUG

Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions

Interventions

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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.

Intervention Type 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 \[7.4 kilobecquerel (kBq)\].

Intervention Type DRUG

Xevinapant 200 mg (Oral Solution)

Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Part 1: Males of any race, between 35 and 65 years of age, inclusive. Part 2: Males of any race, between 18 and 65 years of age, inclusive
* Body mass index between 18.0 and 30.0 kilograms per meter square (kg/m\^2), inclusive
* Weight between 50 kilograms (kg) and 110 kg, inclusive
* History of a minimum of 1 bowel movement per day.
* Willing to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion Criteria

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)
* History of alcohol consumption of \>21 units per week. One unit of alcohol equals 12 ounce (oz) \[360 millilitre (mL)\] beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing, or less than 5 times the half-life, whichever is longer, prior to administration of study drug
* Poor peripheral venous access
* Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Debiopharm International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Labcorp Clinical Research Unit

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Debio 1143-108

Identifier Type: -

Identifier Source: org_study_id