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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519540
• Other study ID #: MS202359_0004
• Secondary ID: 2022-002182-15
• Status: Completed
• Phase: Phase 1
• Start date: September 26, 2022
• Est. completion date: April 21, 2023

Study information

• Verified date: April 2023
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Xevinapant (Debio 1143)
All participants (Japanese and non-Japanese East Asian) will receive single oral dose of xevinapant (Debio 1143) on Day 1.

Locations

Country	Name	City	State
United Kingdom	Labcorp Clinical Research Unit Limited	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of Xevinapant (Debio 1143)		Pre-dose up to 72 hours post-dose
Secondary	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)		up to Day 8
Secondary	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)
Secondary	Pharmacokinetic (PK) Plasma Concentrations of Xevinapant (Debio 1143)		Pre-dose up to 72 hours post-dose
Secondary	Pharmacokinetic (PK) Plasma Concentrations of Metabolite D-1143-MET1		Pre-dose up to 72 hours post-dose

External Links

•   Trial Awareness and Transparency website