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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686096
• Other study ID #: CV029-012
• Status: Completed
• Phase: Phase 1
• Start date: January 16, 2023
• Est. completion date: April 8, 2023

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 8, 2023
• Est. primary completion date: April 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• MYK-224
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Up to 45 days
Primary	Time to maximum observed concentration (Tmax)		Up to 45 days
Primary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))		Up to 45 days
Secondary	Metabolite profiling of BMS-986435 in plasma, urine, and feces		Up to 45 days
Secondary	Number of participants with adverse events (AEs)		Up to 45 days
Secondary	Number of participants with clinical laboratory abnormalities		Up to 45 days
Secondary	Number of participants with vital sign abnormalities		Up to 45 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 45 days
Secondary	Number of participants with physical examination abnormalities		Up to 45 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls