NCT05519540

PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants

A Single-dose, Open-label, Single Arm Study to Investigate PK of Xevinapant (Debio 1143) and Its Metabolite, D-1143-MET1 in Healthy East Asian Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the pharmacokinetics (PK) of Xevinapant (Debio 1143) and its metabolite D-1143-MET1 as well as safety and tolerability of Xevinapant (Debio 1143) in healthy East Asian participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Xevinapant (Debio 1143)	All participants (Japanese and non-Japanese) received a single oral dose of 200mg xevinapant (Debio 1143) on Day 1 under fasted condition.

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-04-21
• Completion: 2023-04-21
• First posted: 2022-08-29
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

1 site across 1 country: United Kingdom