NCT05135871

Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

An Open-Label, Parallel-Group, Single-Center Phase 1 Clinical Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Mavacamten in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: LianBio LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 44 healthy adult Chinese subjects are expected to be enrolled in this study according to their genotypes into 4 cohorts. The doses administered include: 15 mg for cohort 1; 25 mg for Cohort 2; 15 mg for Cohort 3; 15 mg for Cohort 4. Blood samples will be collected from subjects at scheduled time points for PK testing. Series of safety assessments (including but not limited to AEs, laboratory tests, vital signs, and ECGs) will be performed during the whole study at specified time points. This study will consist of the following 5 periods: * Pre-screening period and Screening period (Day -43 to Day -2, up to 42 days) * In-house period (Day -1 to Day 3, total 4 days) * Outpatient period (Day 4 to Day 75, total 72 days): * End of study visit (Day 75)

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
DRUG	Mavacamten	Single fasted oral dose of Mavacamten 15/25 mg on Day 1

Timeline

• Start date: 2021-10-31
• Primary completion: 2022-02-05
• Completion: 2022-02-28
• First posted: 2021-11-26
• Last updated: 2024-07-25
• Results posted: 2024-07-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study