NCT04880213

Study of M5049 in Healthy Japanese and Caucasian Participants

A Phase I, Open-label, Single-dose, Sequential Dose Group Study of Orally Administered M5049 Tablet Formulation in Healthy Japanese and Caucasian Participants to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-05-06
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2021-05-10
• Last updated: 2022-04-06

Locations

1 site across 1 country: United Kingdom