Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants

Launched by CELGENE · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BMS-986365 to understand how safe it is, how the body absorbs it, and how food may affect its levels in the bloodstream. The trial is specifically looking for healthy adult males between the ages of 18 and 65 who meet certain health criteria. To be eligible, participants should have a normal medical history and physical exam, and a body mass index (BMI) between 18 and 32. It’s important that they do not have any serious health conditions, especially related to the heart.

Participants in this study can expect to undergo various tests to ensure their health and to monitor how the medication affects them. The goal is to gather important information about BMS-986365, which could help in its future use. If you or someone you know is interested in joining this study, it's a good idea to discuss it with a healthcare provider to understand all the details and determine eligibility.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
• • Body mass index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive.
• Exclusion Criteria:
• • Any significant acute or chronic illness.
• • Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
• • History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds.
• • Other protocol-defined inclusion/exclusion criteria apply.

Trial Officials