PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Xevinapant (Debio 1143)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05519540

2022-002182-15 (EudraCT Number)

MS202359_0004

Details and patient eligibility

About

The purpose of this study was 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group 1: Japanese Participants: Xevinapant (Debio 1143)

Experimental group

Description:

Xevinapant (Debio 1143) was administered in Healthy Japnaese participants at a dose of 200 milligrams (mg), orally under fasted conditions.

Treatment:

Drug: Xevinapant (Debio 1143)

Group 2: Non-Japanese East Asian Participants: Xevinapant (Debio 1143)

Experimental group

Description:

Xevinapant (Debio 1143) was administered in Healthy Non- Japanese participants at a dose of 200 mg, orally under fasted conditions.

Treatment:

Drug: Xevinapant (Debio 1143)