Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

Sponsor
LianBio LLC
Study ID
NCT05135871
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2021
Status verified
Jun 2024
Primary completion
Feb 5, 2022
Completion
Feb 28, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Mavacamten 15 mg
    Cohort 1: 15 mg capsules × 1 on Day 1
  • Experimental: Cohort 2: Mavacamten 25 mg
    Cohort 2: 10 mg capsules x 1 and 15 mg capsules x 1 on Day 1
  • Experimental: Cohort 3: Mavacamten 15 mg
    Cohort 3: 15 mg capsules × 1 on Day 1
  • Experimental: Cohort 4: Mavacamten 15 mg
    Cohort 4: 15 mg capsules × 1 on Day 1

Primary Outcome Measure

Area Under the Curve (AUC) (0-last), AUC(0-inf) [ Time Frame: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose ]

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