* Phase I PK Study in Healthy East Asian Participants
Research type
Research Study
Full title
A single-dose, open-label, single arm study to investigate PK of xevinapant and its metabolite, MET1 in healthy East Asian participants
IRAS ID
1005971
Contact name
Safa Khan
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2022-002182-15
Clinicaltrials.gov Identifier
Research summary
This is a single-dose, open-label study evaluating the pharmacokinetics (how the body handles the drug) and safety of xevinapant (the study drug) in healthy east Asian participants. At least 10 Japanese and 10 non-Japanese East Asian participants will be enrolled, with a planned total duration of the study for each participant of approximately 5 weeks, including an up to 4-week screening period, an in-house period from Day-1 to Day 4, and a safety follow-up on Day 8.
All participants will be dosed on Day 1 with a single oral 200 mg dose of xevinapant. Group 1 will enrol at least 10 Japanese participants and Group 2 will enrol at least 10 non-Japanese East Asian participants. East Asia includes Korea and Greater China.Xevinapant is a novel orally available drug in development. It acts as an antagonist of IAPs (Inhibitor of Apoptosis Proteins) and promotes cancer cell death via a process known as apoptosis.
Xevinapant potentially sensitizes tumour cells for various cytotoxic (cell-killing) therapies, including chemotherapy, radiotherapy, and/or immunotherapy.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0351
Date of REC Opinion
12 Aug 2022
REC opinion
Further Information Favourable Opinion