Clinical trial NCT05519540: PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: East Asian
Japanese
Pharmacokinetic
Ethnic sensitivity
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2022-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Xevinapant (Debio 1143)
timeFrame: Pre-dose up to 72 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) of Xevinapant (Debio 1143)
timeFrame: Pre-dose up to 72 hours post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of Xevinapant (Debio 1143)
timeFrame: Pre-dose up to 72 hours post-dose
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: up to Day 8
measure: Number of Participants with Clinically Significant Changes from Baseline Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
timeFrame: up to end of treatment (Day 4)
measure: Pharmacokinetic (PK) Plasma Concentrations of Xevinapant (Debio 1143)
timeFrame: Pre-dose up to 72 hours post-dose
measure: Pharmacokinetic (PK) Plasma Concentrations of Metabolite D-1143-MET1
timeFrame: Pre-dose up to 72 hours post-dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Labcorp Clinical Research Unit Limited
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: