Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

NCT ID: NCT05135871

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-02-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Mavacamten 15 mg

Cohort 1: 15 mg capsules × 1 on Day 1

Group Type: EXPERIMENTAL

Mavacamten

Intervention Type: DRUG

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

Cohort 2: Mavacamten 25 mg

Cohort 2: 10 mg capsules x 1 and 15 mg capsules x 1 on Day 1

Group Type: EXPERIMENTAL

Mavacamten

Intervention Type: DRUG

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

Cohort 3: Mavacamten 15 mg

Cohort 3: 15 mg capsules × 1 on Day 1

Group Type: EXPERIMENTAL

Mavacamten

Intervention Type: DRUG

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

Cohort 4: Mavacamten 15 mg

Cohort 4: 15 mg capsules × 1 on Day 1

Group Type: EXPERIMENTAL

Mavacamten

Intervention Type: DRUG

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

Interventions

Mavacamten

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

Intervention Type: DRUG

Other Intervention Names

Mavacamten capsule

Eligibility Criteria

Inclusion Criteria

• Male or female between the ages of 18 and 60 (inclusive) at screening
• With a body mass index (BMI) between 18 kg/m2 and 30 kg/m2 (inclusive) at screening
• Healthy as determined at screening and on Day -1
• Female subjects shall not be pregnant or breastfeeding
• Male partners of female subjects must also adopt a contraceptive method from screening through 5 months after administration of the investigational drug
• Able to understand and comply with the study procedures, understand the risks involved in this study, and provide written informed consent according to local and institutional guidelines before screening procedure

Exclusion Criteria

• History of clinically significant arrhythmia
• History of any type of malignant tumors within 5 years of the Screening Visit
• Positive serologic tests at screening for infections with human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B virus (HBV) surface antigen at screening
• The vital signs of screening period and Day -1 were unqualified
• Subjects who have taken prescription medications within 28 days prior to screening or within 5 times of T1/2 (if known), whichever is longer
• History or evidence of any other clinically significant abnormalities, conditions, or diseases that, in the opinion of the investigator, would pose a risk to the safety of the subject or interfere with study evaluation, procedures, or its completion
• Any condition or treatment for a condition that might interfere with the conduct of the trial or might, in the opinion of the investigator, put the subject at risk, including but not limited to, alcoholism, drug dependence or abuse, and psychiatric conditions, if he/she participates in this study
• Positive test for alcohol or drug abuse at screening and on Day -1
• Use of tobacco within 28 days prior to screening
• Hypersensitivity to mavacamten or any of the components of its formulation
• Prior exposure to mavacamten
• Unable to comply with the study restrictions/requirements, including the number of required visits to the clinical site
• Unsuitable to participate in the study as judged by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LianBio LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39014868 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LB2001-101

Identifier Type: -

Identifier Source: org_study_id