PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants
- Registration Number
- NCT05519540
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1: Japanese: Xevinapant (Debio 1143) Xevinapant (Debio 1143) - Group 2: Non-Japanese East Asian: Xevinapant (Debio 1143) Xevinapant (Debio 1143) -
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Xevinapant (Debio 1143) Pre-dose up to 72 hours post-dose Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) of Xevinapant (Debio 1143) Pre-dose up to 72 hours post-dose Maximum Observed Plasma Concentration (Cmax) of Xevinapant (Debio 1143) Pre-dose up to 72 hours post-dose
- Secondary Outcome Measures
Name Time Method Number of Participants with Treatment-Emergent Adverse Events (TEAEs) up to Day 8 Number of Participants with Clinically Significant Changes from Baseline Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements up to end of treatment (Day 4) Pharmacokinetic (PK) Plasma Concentrations of Xevinapant (Debio 1143) Pre-dose up to 72 hours post-dose Pharmacokinetic (PK) Plasma Concentrations of Metabolite D-1143-MET1 Pre-dose up to 72 hours post-dose
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Limited
🇬🇧Leeds, United Kingdom