A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants

NCT ID: NCT05304533

Last Updated: 2023-01-13

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2022-11-29

Brief Summary

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The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: MYK-224

Group Type EXPERIMENTAL

MYK-224

Intervention Type DRUG

Specified dose on specified days

Arm 2: MYK-224 + Itraconazole

Group Type EXPERIMENTAL

MYK-224

Intervention Type DRUG

Specified dose on specified days

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Arm 3: MYK-224 + Verapamil

Group Type EXPERIMENTAL

MYK-224

Intervention Type DRUG

Specified dose on specified days

Verapamil

Intervention Type DRUG

Specified dose on specified days

Interventions

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MYK-224

Specified dose on specified days

Intervention Type DRUG

Itraconazole

Specified dose on specified days

Intervention Type DRUG

Verapamil

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986435

Eligibility Criteria

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Inclusion Criteria

* Body mass index between 18 and 30 kg/m\^2, inclusive
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments
* Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment
* Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing

Exclusion Criteria

* Any acute or chronic medical illness
* History of dizziness and/or recurrent headaches
* History of heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Local Institution - 0001

Dallas, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV029-005

Identifier Type: -

Identifier Source: org_study_id

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