A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435

NCT ID: NCT05686096

Last Updated: 2023-05-25

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2023-04-08

Brief Summary

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The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants

Participants will be admitted to the study site for 3 weeks.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MYK-224

Group Type EXPERIMENTAL

MYK-224

Intervention Type DRUG

Specified dose on specified days

Interventions

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MYK-224

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 32 kg/m\^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
* Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
* Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.

Exclusion Criteria

* Any acute or chronic medical illness.
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV029-012

Identifier Type: -

Identifier Source: org_study_id

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