CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Xevinapant (Debio 1143)drug
Likely dose
Xevinapant (Debio 1143) 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05519540
NCT05519540Phase 1Completed
CompareCT.gov

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

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Aug 29, 2022·Updated Aug 20, 2025

In Brief

A Phase 1 clinical trial evaluating Xevinapant (Debio 1143) for Healthy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedAug 29, 2022
Enrollment StartSep 26, 2022
Primary CompletionApr 21, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.8 years ago

Interventions

Xevinapant (Debio 1143)drug

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