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

MS202359_0004

The purpose of this study is 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.

2022-09-26

2023-04-21

2023-04-21

Completed

Early phase I

24

Inclusion Criteria: * Healthy participant of Japanese or other East Asian origin. Group 1: Japanese participants must be first generation (born in Japan) with both biological parents and all 4 biological grandparents being Japanese native born, lived for less than (\<)10 years outside of Japan, and have no significant change in lifestyle since leaving Japan. Group 2: Other non-Japanese East Asian participants must have both biological parents and 4 biological grandparents of East Asian descent, lived for \<10 years outside of their countries, and have no significant change in lifestyle since leaving from there. East Asia includes Korea or Greater China * Overtly healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring (blood pressure, heart rate, and 12-lead resting ECG) * Have a body weight within 50 and 110 kilograms \[kg\] (inclusive) and Body Mass Index (BMI) within the range 18.0 to 32.0 kilograms per meter square \[Kg/m\^2\] (inclusive) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant * History of relevant drug hypersensitivity, ascertained or presumptive allergy/ hypersensitivity to the active drug substance and/or formulation ingredients history of serious allergic reactions leading to hospitalization or any other allergy reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the study * Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)), bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives less than or equal to (\<=) 4 weeks prior to or during Screening Period, or completion of oral anti-infectives \<= 2 weeks prior to Screening Visit. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered to be sufficiently controlled will not be exclusionary * History of splenectomy * History of any malignancy (hematologic or solid tumor) before the Screening Visit, except for adequately treated superficial basal cell carcinoma of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix * History of or a positive screening test for hepatitis B, hepatitis C, or human immunodeficiency virus type I and II * Use of any investigational drug in any clinical study within 5 half-lives from last administration * Other protocol defined exclusion criteria could apply

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2023-04-27