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OpenTrials
Completed

NCT Number: NCT05686096

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MYK-224

Drug

Specified dose on specified days

Other names: BMS-986435

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 45 days

  2. Time to maximum observed concentration (Tmax)

    Time frame: Up to 45 days

  3. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

    Time frame: Up to 45 days

Secondary outcomes

  1. Metabolite profiling of BMS-986435 in plasma, urine, and feces

    Time frame: Up to 45 days

  2. Number of participants with adverse events (AEs)

    Time frame: Up to 45 days

  3. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 45 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 45 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 45 days

  6. Number of participants with physical examination abnormalities

    Time frame: Up to 45 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Open-label, Single Dose Study to Assess the Absorption, Metabolism, and Excretion of [14C]BMS-986435 in Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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