Study of M5049 in Healthy Japanese and Caucasian Participants

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: M5049

Study type: Interventional

Funder types: Industry

Identifiers

NCT04880213

2020-005408-20 (EudraCT Number)

MS200569_0005

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Japanese: M5049 Dose A (low dose)

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Japanese: M5049 Dose B (medium dose)

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Japanese: M5049 Dose C (high dose)

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Caucasian: M5049 Dose A (low dose)

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Caucasian: M5049 Dose B (medium dose)

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049

Caucasian: M5049 Dose C (high dose)

Experimental group

Treatment:

Drug: M5049

Drug: M5049

Drug: M5049