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

Debiopharm

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Xevinapant 200 mg (Oral Solution); Drug: Radiolabelled Xevinapant 100 μg (IV Solution); Drug: Radiolabelled Xevinapant 200 mg (Oral Solution)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04962724

Debio 1143-108

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Radiolabeled Xevinapant Oral Solution

Experimental group

Description:

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

Treatment:

Drug: Radiolabelled Xevinapant 200 mg (Oral Solution)

Radiolabeled Xevinapant Intravenous Solution + Xevinapant Oral Solution

Experimental group

Description:

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

Treatment:

Drug: Xevinapant 200 mg (Oral Solution)

Drug: Radiolabelled Xevinapant 100 μg (IV Solution)