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* 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

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