Study of M5049 in Healthy Japanese and Caucasian Participants
- Registration Number
- NCT04880213
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
The purpose of this study is to evaluate and determine the safety, tolerability and pharmacokinetics of single-doses of M5049 up to 3 dose levels administered as film-coated tablet under fasted conditions in healthy Japanese and Caucasian participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Japanese participants must be first generation (born in Japan) with both biological parents and all 4 biological grandparents being Japanese native born. Caucasian participants must have both biological parents and 4 biological grandparents of Caucasian descent
- 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)
- Participants with body weight within 45 to 90 kilograms (kg) (female) and 55 to 90 kg (male) and body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m^2)
- A Caucasian participant will be matched by body weight (± 20% body weight [kg]), height (± 15% height [centimeter (cm) ]) and sex to each Japanese participant
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Participants with 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
- Participants with history of relevant drug hypersensitivity
- Participants with history of splenectomy, epilepsy, other neurological disorders or neuropsychiatric conditions
- Participants with history of a tuberculosis and positive Screening test for hepatitis B surface antigen
- Participants with history of alcoholism or drug abuse
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Japanese: M5049 Dose B (medium dose) M5049 - Caucasian: M5049 Dose C (high dose) M5049 - Caucasian: M5049 Dose A (low dose) M5049 - Japanese: M5049 Dose A (low dose) M5049 - Japanese: M5049 Dose C (high dose) M5049 - Caucasian: M5049 Dose B (medium dose) M5049 -
- Primary Outcome Measures
Name Time Method Number of Participants with Clinically Significant Changes from Baseline in Vital Signs Baseline up to Day 3 Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECGs) Findings Baseline up to Day 3 Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death Baseline up to Day 8 Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters Baseline up to Day 3 Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (tlast) (AUC0-tlast) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose Maximum Observed Plasma Concentration (Cmax) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Curve From Time Zero to 48 Hours Post-dose (AUC0-48) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose Terminal Half-life (t1/2) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose Apparent Volume of Distribution (Vz/f) During Terminal Phase of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose Time to Reach Maximum Plasma Concentration (tmax) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose Apparent Total Body Clearance (CL/f) of M5049 Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Trial Locations
- Locations (1)
Covance Clinical Research Unit Ltd.
🇬🇧Leeds, United Kingdom