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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: MYK-224

Study type

Interventional

Funder types

Industry

Identifiers

NCT05686096
CV029-012

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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).

Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

MYK-224
Experimental group
Treatment:
Drug: MYK-224

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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