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Small-molecule allosteric inhibitor
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Phase 1
Waitlist Available
Led By Jing Zhang, Doctor
Research Sponsored by LianBio LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, day 1, day 7, day 10, day 14, day 21, day 28, day 35, day 45, day 67 and day 75 post-dose
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Hypertrophic Cardiomyopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, day 1, day 7, day 10, day 14, day 21, day 28, day 35, day 45, day 67 and day 75 post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, day 1, day 7, day 10, day 14, day 21, day 28, day 35, day 45, day 67 and day 75 post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apparent Clearance (CL/F)
Apparent Volume of Distribution (Vd/F)
Area Under the Curve (AUC) (0-last), AUC(0-inf)
+3 moreSecondary study objectives
Body Weight at Screening and EOS
Clinical Laboratory Tests Data
Heart Rate at Baseline and Day 75
+2 moreSide effects data
From 2024 Phase 3 trial • 112 Patients • NCT043490729%
Fatigue
8%
Dizziness
7%
Headache
6%
Dyspnoea
6%
Palpitations
6%
Dyspnoea exertional
6%
Hypertension
6%
Arthralgia
3%
Atrial fibrillation
1%
Peripheral venous disease
1%
Cardiac failure congestive
1%
Acute respiratory failure
1%
Gastrooesophageal reflux disease
1%
Sudden cardiac death
1%
Fall
1%
Large intestine perforation
1%
Pneumatosis intestinalis
1%
Nephrolithiasis
1%
Pulmonary embolism
1%
COVID-19
1%
Clostridium difficile infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mavacamten
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: Mavacamten 15 mgExperimental Treatment1 Intervention
Cohort 4: 15 mg capsules × 1 on Day 1
Group II: Cohort 3: Mavacamten 15 mgExperimental Treatment1 Intervention
Cohort 3: 15 mg capsules × 1 on Day 1
Group III: Cohort 2: Mavacamten 25 mgExperimental Treatment1 Intervention
Cohort 2: 10 mg capsules x 1 and 15 mg capsules x 1 on Day 1
Group IV: Cohort 1: Mavacamten 15 mgExperimental Treatment1 Intervention
Cohort 1: 15 mg capsules × 1 on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavacamten
2022
Completed Phase 3
~530
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
LianBio LLCLead Sponsor
6 Previous Clinical Trials
341 Total Patients Enrolled
Jing Zhang, DoctorPrincipal InvestigatorHuashan Hospital
3 Previous Clinical Trials
310 Total Patients Enrolled