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Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

Primary Purpose

Hypertrophic Cardiomyopathy

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Mavacamten

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring Mavacamten

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Key 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

Key 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

Sites / Locations

Huashan Hospital Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1: Mavacamten 15 mg

Cohort 2: Mavacamten 25 mg

Cohort 3: Mavacamten 15 mg

Cohort 4: Mavacamten 15 mg

Arm Description

Cohort 1: 15 mg capsules × 1 on Day 1

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

Cohort 3: 15 mg capsules × 1 on Day 1

Cohort 4: 15 mg capsules × 1 on Day 1

Outcomes

Primary Outcome Measures

Area under the curve (AUC) (0-last), AUC(0-inf)

Determination of pharmacokinetics parameters as measured by area under curve AUC(0-last), AUC(0-inf)

Maximum concentration (Cmax)

Determination of pharmacokinetics parameters as measured by maximum concentration (Cmax)

Time to maximum concentration (Tmax)

Determination of pharmacokinetics parameters as measured by time to maximum concentration (Tmax)

Elimination half-life (T1⁄2)

Determination of pharmacokinetics parameters as measured by elimination half-life (T1⁄2)

Apparent volume of distribution (Vd/F)

Determination of pharmacokinetics parameters as measured by apparent volume of distribution (Vd/F)

Apparent clearance (CL/F)

Determination of pharmacokinetics parameters as measured by apparent clearance (CL/F)

Secondary Outcome Measures

Incidence of adverse events

Safety assessments will be performed by incidence of adverse events during the whole study at specified time points

Vital signs

Safety assessments will be performed by vital signs during the whole study at specified time points

Physical examination findings

Safety assessments will be performed by physical examination findings during the whole study at specified time points

Electrocardiogram (ECG) parameters

Safety assessments will be performed by electrocardiogram (ECG) parameters findings during the whole study at specified time points

Clinical laboratory tests data

Safety assessments will be performed by clinical laboratory tests data(including hematology and blood chemistry, coagulation and urinalysis parameters) during the whole study at specified time points

Full Information

NCT ID

NCT05135871

First Posted

October 28, 2021

Last Updated

July 28, 2022

Sponsor

LianBio LLC

1. Study Identification

Unique Protocol Identification Number

NCT05135871

Brief Title

Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

October 31, 2021 (Actual)

Primary Completion Date

February 5, 2022 (Actual)

Study Completion Date

February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LianBio LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Cardiomyopathy

Keywords

Mavacamten

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Mavacamten 15 mg

Arm Type

Experimental

Arm Description

Cohort 1: 15 mg capsules × 1 on Day 1

Arm Title

Cohort 2: Mavacamten 25 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3: Mavacamten 15 mg

Arm Type

Experimental

Arm Description

Cohort 3: 15 mg capsules × 1 on Day 1

Arm Title

Cohort 4: Mavacamten 15 mg

Arm Type

Experimental

Arm Description

Cohort 4: 15 mg capsules × 1 on Day 1

Intervention Type

Drug

Intervention Name(s)

Mavacamten

Other Intervention Name(s)

Mavacamten capsule

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the curve (AUC) (0-last), AUC(0-inf)

Description

Determination of pharmacokinetics parameters as measured by area under curve AUC(0-last), AUC(0-inf)

Time Frame