* 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

  submissions@labcorp.com

• Sponsor organisation

  Merck Healthcare KGaA

• Eudract number

  2022-002182-15

• 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