Study of M5049 in Healthy Japanese and Caucasian Participants

Phase 1 Completed 36 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Non-randomizedSequentialOpen-labelOther

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.

Timeline

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

Publications

Klopp-Schulze L, Gopalakrishnan S, Yalkinoglu O, Kuroki Y, Lu H, Goteti K, Krebs-Brown A, Nogueira Filho M, Gradhand U, Fluck M, Shaw J, Dong J, Venkatakrishnan K. Asia-Inclusive Global Development of Enpatoran: Results of an Ethno-Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial. Clin Pharmacol Ther. 2024 Jun;115(6):1346-1357. doi: 10.1002/cpt.3216. Epub 2024 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enpatoran	Small molecule	100 mg	Oral
Subject	Enpatoran	Small molecule	200 mg	Oral
Subject	Enpatoran	Small molecule	300 mg	Oral

Indications

No indication recorded.