Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

Summary

Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and improving ventricular compliance. This is an open-label, parallel-group, single-center Phase 1 clinical study. Healthy adult Chinese subjects with different genotypes will be included and administered with a single fasted oral dose of mavacamten to evaluate its PK profile. Up to 44 subjects will be enrolled in this study.

Timeline

Start

2021-10-31

Primary completion

2022-02-05

Completion

2022-02-28

Publications

• Wu X, Chen N, Hsu P, Sun J, Li W, Wang Q, Samira M, Wei Q, Yu J, Cao G, Yang H, Wang L, Wang J, Jin Y, Liu W, Wu J, He J, Lyu C, Zhang J. Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypes. Clin Transl Sci. 2024 Jul;17(7):e13877. doi: 10.1111/cts.13877.

Drugs

Indications