NCT05658146

Brief Summary

The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

January 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

December 13, 2022

Last Update Submit

October 10, 2023

Conditions

Healthy Participants

Keywords

Healthy ParticipantsMavacamtenBioequivalence

Outcome Measures

Primary Outcomes (3)

  • Maximum Observed Serum Concentration (Cmax)

    From Day 1 up to Day 35±2 of each period

  • Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]

    From Day 1 up to Day 35±2 of each period

  • Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]

    From Day 1 up to Day 35±2 of each period

Secondary Outcomes (9)

  • Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]

    From Day 1 to Day 4 of each period

  • Time of Maximum Observed Serum Concentration (Tmax)

    From Day 1 up to Day 35±2 of each period

  • Terminal Half-life (T-HALF)

    From Day 1 up to Day 35±2 of each period

  • Number of Participants with Adverse Events (AEs)

    Up to 35 days post discontinuation of dosing

  • Number of Participants with Serious Adverse Events (SAEs)

    Up to 35 days post discontinuation of dosing

  • +4 more secondary outcomes

Study Arms (6)

Sequence 1

EXPERIMENTAL
Drug: Mavacamten Capsule 1Drug: Mavacamten Capsule 2Drug: Mavacamten Capsule 3

Sequence 2

EXPERIMENTAL
Drug: Mavacamten Capsule 1Drug: Mavacamten Capsule 2Drug: Mavacamten Capsule 3

Sequence 3

EXPERIMENTAL
Drug: Mavacamten Capsule 1Drug: Mavacamten Capsule 2Drug: Mavacamten Capsule 3

Sequence 4

EXPERIMENTAL
Drug: Mavacamten Capsule 1Drug: Mavacamten Capsule 2Drug: Mavacamten Capsule 3

Sequence 5

EXPERIMENTAL
Drug: Mavacamten Capsule 1Drug: Mavacamten Capsule 2Drug: Mavacamten Capsule 3

Sequence 6

EXPERIMENTAL
Drug: Mavacamten Capsule 1Drug: Mavacamten Capsule 2Drug: Mavacamten Capsule 3

Interventions

Mavacamten Capsule 1DRUG

Specified dose on specified days

Also known as: BMS-986427, MYK-461
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Mavacamten Capsule 2DRUG

Specified dose on specified days

Also known as: BMS-986427, MYK-461
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Mavacamten Capsule 3DRUG

Specified dose on specified days

Also known as: BMS-986427, MYK-461
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index between 18 and 32 kilograms/meter squared (kg/m\^2) inclusive, at the screening visit.
  • Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
  • Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.

You may not qualify if:

  • Any significant acute or chronic medical illness.
  • Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
  • CYP2C19 poor (\*2/\*2, \*3/\*3, or \*2/\*3) or intermediate (\*1/\*2, \*1/\*3, \*2/\*17) metabolizer, as determined by genotyping during screening.
  • Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution - 0001

Anaheim, California, 92801, United States

Location

Local Institution - 0002

Miami, Florida, 33126, United States

Location

Local Institution - 0003

Springfield, Missouri, 65802, United States

Location

Related Links

MeSH Terms

Interventions

MYK-461

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 20, 2022

Study Start

January 6, 2023

Primary Completion

July 5, 2023

Study Completion

July 5, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)