Hypertrophic CardiomyopathyPhase 1NCT05135871

Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects

A Phase 1 study testing Mavacamten in people with Hypertrophic Cardiomyopathy, run by LianBio LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Hypertrophic Cardiomyopathy
What is being tested?: Mavacamten
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteChina
Study dates: 31 Oct 2021to 28 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

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

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.

Read the 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
Being tested: Mavacamten
Keywords: Mavacamten
Medical subject headings: Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MavacamtenDrug
Also called Mavacamten capsule
Single fasted oral dose of Mavacamten 15/25 mg on Day 1

Study groups in NCT05135871
Study group	Role	What they receive
Cohort 1: Mavacamten 15 mg	Experimental	Cohort 1: 15 mg capsules × 1 on Day 1 Receives: Drug: Mavacamten
Cohort 2: Mavacamten 25 mg	Experimental	Cohort 2: 10 mg capsules x 1 and 15 mg capsules x 1 on Day 1 Receives: Drug: Mavacamten
Cohort 3: Mavacamten 15 mg	Experimental	Cohort 3: 15 mg capsules × 1 on Day 1 Receives: Drug: Mavacamten
Cohort 4: Mavacamten 15 mg	Experimental	Cohort 4: 15 mg capsules × 1 on Day 1 Receives: Drug: Mavacamten

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose
Maximum Concentration (Cmax)
Determination of pharmacokinetics parameters as measured by maximum concentration (Cmax)
Measured: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose
Time to Maximum Concentration (Tmax)
Determination of pharmacokinetics parameters as measured by time to maximum concentration (Tmax)
Measured: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose
Elimination Half-life (T1⁄2)
Determination of pharmacokinetics parameters as measured by elimination half-life (T1⁄2)
Measured: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose
Apparent Volume of Distribution (Vd/F)
Determination of pharmacokinetics parameters as measured by apparent volume of distribution (Vd/F)
Measured: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose
Apparent Clearance (CL/F)
Determination of pharmacokinetics parameters as measured by apparent clearance (CL/F)
Measured: Predose, Day 1, Day 7, Day 10, Day 14, Day 21, Day 28, Day 35, Day 45, Day 67 and Day 75 post-dose

Secondary outcomes (5)

Number of Participants With Adverse Events
Safety assessments will be performed by incidence of adverse events during the whole study at specified time points
Measured: Up to 75 days
Body Weight at Screening and EOS
Safety assessments will be performed by vital signs during the whole study at screening, Day-1, Day 3 and at the EOS Visit. A complete physical examination includes assessments of general appearance, skin, head and neck, chest, abdomen, back, spine, extremity neurological, and mental systems. Brief physical examination means chest examinations.
Height (cm) and body weight (kg) will be measured at screening, and BMI (kg/m2) will be calculated. Body weight (kg) will be measured at EOS. The mean weight and the standard deviation are analysis for different cohort.
Measured: Body weight (kg) will be measured at screening (baseline) and EOS(75 days).
Physical Examination Findings
Safety assessments will be performed by physical examination findings during the whole study at specified time points
Measured: Up to 75 days
Heart Rate at Baseline and Day 75
Safety assessments will be performed by electrocardiogram (ECG) parameters findings during the whole study at specified time points
Measured: Up to 75 days
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
Measured: Up to 75 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202128 Feb 2022

First posted26 Nov 2021
Study start31 Oct 2021
Primary completion5 Feb 2022
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05135871
Sponsor's protocol ID: LB2001-101
Status last verified: Jun 2024
First submitted: 28 Oct 2021
Last updated: 25 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39014868

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertrophic Cardiomyopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05135871
Acronym / sponsor ID: LB2001-101
Conditions: Hypertrophic Cardiomyopathy
Keywords: Mavacamten
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: LianBio LLCIndustry (pharma, biotech, devices)
Study start: 31 Oct 2021 (actual)
Primary completion: 5 Feb 2022 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 26 Nov 2021 (actual)
Results: Posted 25 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 44 healthy adult Chinese subjects are expected to be enrolled in this study according to their genotypes into 4 cohorts.

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)

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort 1: Mavacamten 15 mg	Experimental	Drug: MavacamtenCohort 1: 15 mg capsules × 1 on Day 1
Cohort 2: Mavacamten 25 mg	Experimental	Drug: MavacamtenCohort 2: 10 mg capsules x 1 and 15 mg capsules x 1 on Day 1
Cohort 3: Mavacamten 15 mg	Experimental	Drug: MavacamtenCohort 3: 15 mg capsules × 1 on Day 1
Cohort 4: Mavacamten 15 mg	Experimental	Drug: MavacamtenCohort 4: 15 mg capsules × 1 on Day 1

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MavacamtenAlso: Mavacamten capsuleSingle fasted oral dose of Mavacamten 15/25 mg on Day 1	Drug	Cohort 1: Mavacamten 15 mg, Cohort 2: Mavacamten 25 mg, Cohort 3: Mavacamten 15 mg, Cohort 4: Mavacamten 15 mg

Primary outcome

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
Determination of pharmacokinetics parameters as measured by area under curve AUC(0-last), AUC(0-inf)
Maximum Concentration (Cmax)
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
Determination of pharmacokinetics parameters as measured by maximum concentration (Cmax)
Time to Maximum Concentration (Tmax)
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
Determination of pharmacokinetics parameters as measured by time to maximum concentration (Tmax)
Elimination Half-life (T1⁄2)
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
Determination of pharmacokinetics parameters as measured by elimination half-life (T1⁄2)
Apparent Volume of Distribution (Vd/F)
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
Determination of pharmacokinetics parameters as measured by apparent volume of distribution (Vd/F)
Apparent Clearance (CL/F)
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
Determination of pharmacokinetics parameters as measured by apparent clearance (CL/F)

5 secondary outcomes

Number of Participants With Adverse Events
Time frame: Up to 75 days
Body Weight at Screening and EOS
Time frame: Body weight (kg) will be measured at screening (baseline) and EOS(75 days).
Physical Examination Findings
Time frame: Up to 75 days
Heart Rate at Baseline and Day 75
Time frame: Up to 75 days
Clinical Laboratory Tests Data
Time frame: Up to 75 days

Results and safety

Results posted to the registry on 25 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 2: Mavacamten 25 mg	13	12
Cohort 1: Mavacamten 15 mg	12	12
Cohort 3: Mavacamten 15 mg	12	12
Cohort 4: Mavacamten 15 mg	8	8

Primary outcome: 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. Geometric mean (Standard Deviation). Unit: h*ng/mL

Measure	Cohort 1: Mavacamten 15 mg n = 12	Cohort 2: Mavacamten 25 mg n = 12	Cohort 3: Mavacamten 15 mg n = 11	Cohort 4: Mavacamten 15 mg n = 8
(AUC) (0-last)	9956 (35.61)	20040 (50.49)	18270 (21.05)	39980 (23.60)
AUC(0-inf)	10030 (35.44)	20280 (52.47)	18430 (21.18)	45810 (25.51)

Population analysed: One subject (Cohort 3) was excluded from the pharmacokinetic analysis set due to a major protocol deviation (use of prohibited drug moderate-acting CYP2C19 inhibitor "Omeprazole") affecting the assessment of PK parameters.

Primary outcome: Maximum Concentration (Cmax)

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. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 1: Mavacamten 15 mg n = 12	Cohort 2: Mavacamten 25 mg n = 12	Cohort 3: Mavacamten 15 mg n = 11	Cohort 4: Mavacamten 15 mg n = 8
Value	395.4 (39.95)	571.8 (25.69)	485.2 (34.96)	435.7 (35.66)

Primary outcome: Time to Maximum Concentration (Tmax)

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. Median (Full Range). Unit: h

Measure	Cohort 1: Mavacamten 15 mg n = 12	Cohort 2: Mavacamten 25 mg n = 12	Cohort 3: Mavacamten 15 mg n = 11	Cohort 4: Mavacamten 15 mg n = 8
Value	0.88 (0.50 to 3.00)	1.50 (0.50 to 4.00)	0.75 (0.50 to 3.00)	0.63 (0.33 to 1.00)

Primary outcome: Elimination Half-life (T1⁄2)

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. Geometric mean (Standard Deviation). Unit: h

Measure	Cohort 1: Mavacamten 15 mg n = 12	Cohort 2: Mavacamten 25 mg n = 12	Cohort 3: Mavacamten 15 mg n = 11	Cohort 4: Mavacamten 15 mg n = 8
Value	120.3 (23.44)	143.6 (42.32)	205.4 (22.31)	572.0 (25.03)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study took about 80 days to monitor the adverse event for each subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Mavacamten 15 mg	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Cohort 2: Mavacamten 25 mg	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Cohort 3: Mavacamten 15 mg	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Cohort 4: Mavacamten 15 mg	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Limitations and caveats (from the sponsor): There are no special limitations and caveats to this trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39014868Wu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jing Zhang, Doctor principal investigator

Huashan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mavacamten in people with Hypertrophic Cardiomyopathy, run by LianBio LLC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05135871, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.