A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

Launched by CELGENE · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new drug called BMS-986365 to understand how it is processed in the body. Specifically, the study aims to find out how well the drug is absorbed, how it breaks down, and how it is eliminated from the body in healthy male volunteers. This is an early phase study, meaning it’s one of the first steps in testing this drug in people.

To be eligible for this study, participants need to be healthy males between the ages of 18 and 55, with a body mass index (BMI) between 18.0 and 32.0. They should not have any significant health issues or a history of heart problems. If chosen to participate, volunteers can expect to undergo health checks and monitoring throughout the study to ensure their safety. This trial is currently recruiting participants, and it’s important for anyone considering joining to talk to their doctor about the details and any potential risks involved.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
• • Participants will require a left ventricular ejection fraction of \> 50% at screening.
• • Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2.
• Exclusion Criteria:
• • Any current or recent significant acute or chronic illness.
• • Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening.
• • Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
• • History of allergy to BMS-986365 or related compounds.
• • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Officials