pk study of xevinapant (debio 1143) in healthy east asian participants

Conditions: Healthy

Summary: 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.


Eligibility criteria:
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

Keywords: east asian japanese pharmacokinetic ethnic sensitivity