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Study of M5049 in Healthy Japanese and Caucasian Participants

NCT04880213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-04-06

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

M5049

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

DRUG

M5049

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

DRUG

M5049

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

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2021-11-23
Completion
2021-11-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880213 on ClinicalTrials.gov