Study of M5049 in Healthy Japanese and Caucasian Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2021-11-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Japanese: M5049 Dose A (low dose)

Group Type EXPERIMENTAL

M5049

Intervention Type DRUG

Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition.

Japanese: M5049 Dose B (medium dose)

Group Type EXPERIMENTAL

M5049

Intervention Type DRUG

Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition.

Japanese: M5049 Dose C (high dose)

Group Type EXPERIMENTAL

M5049

Intervention Type DRUG

Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition.

Caucasian: M5049 Dose A (low dose)

Group Type EXPERIMENTAL

M5049

Intervention Type DRUG

Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition.

Caucasian: M5049 Dose B (medium dose)

Group Type EXPERIMENTAL

M5049

Intervention Type DRUG

Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition.

Caucasian: M5049 Dose C (high dose)

Group Type EXPERIMENTAL

M5049

Intervention Type DRUG

Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition.

Interventions

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M5049

Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition.

Intervention Type DRUG

M5049

Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition.

Intervention Type DRUG

M5049

Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes