CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 45 enrolled
Drug / intervention
Mavacamtendrug
Likely dose
Mavacamten 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05135871
NCT05135871Phase 1Completed
CompareCT.gov

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

LianBio LLC·interventional·Posted Nov 26, 2021·Updated Jul 25, 2024

In Brief

A Phase 1 clinical trial evaluating Mavacamten for Hypertrophic Cardiomyopathy. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertrophic Cardiomyopathy
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedNov 26, 2021
Enrollment StartOct 31, 2021
Primary CompletionFeb 5, 2022
Study CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.6 years ago

Interventions

Mavacamtendrug

Single fasted oral dose of Mavacamten 15/25 mg on Day 1