A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

NCT ID: NCT05362045

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-16

Study Completion Date

2022-08-19

Brief Summary

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

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mavacamten- Dose A

Group Type EXPERIMENTAL

Mavacamten

Intervention Type DRUG

Specified dose on specified days

Mavacamten- Dose B

Group Type EXPERIMENTAL

Mavacamten

Intervention Type DRUG

Specified dose on specified days

Interventions

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Mavacamten

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986427 MYK-461

Eligibility Criteria

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Inclusion Criteria

* Body mass index between 18 and 32 kg/m\^2, inclusive, at the Screening Visit
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1

Exclusion Criteria

* Current or recent (within 3 months of study intervention administration) gastrointestinal disease
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Clinical pharmacology of Miami

Miami, Florida, United States

Site Status

Advanced Pharma CR, LLC

Miami, Florida, United States

Site Status

QPS Springfield

Springfield, Missouri, United States

Site Status

Ppd Phase I Clinic

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV027-070

Identifier Type: -

Identifier Source: org_study_id

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