Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
| Status | Not yet recruiting |
| Enrollment | 24 |
| Est. completion date | September 23, 2024 |
| Est. primary completion date | September 23, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0001 | Madison | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed concentration (Cmax) | Part A and B | Up to Day 60 | |
| Primary | Time of maximum observed concentration (Tmax) | Part A and B | Up to Day 60 | |
| Primary | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Part A and B | Up to Day 60 | |
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF)) | Part A and B | Up to Day 60 | |
| Primary | Apparent terminal plasma half-life (T-HALF) | Part A and B | Up to Day 60 | |
| Primary | Total body clearance (CLT) | Part A | Up to Day 15 | |
| Primary | Apparent total body clearance (CLT/F) | Part A and B | Up to Day 60 | |
| Primary | Mean residence time (MRT) | Part A | Up to Day 15 | |
| Primary | Apparent volume of distribution (Vz) | Part A | Up to Day 15 | |
| Primary | Apparent volume of distribution (Vz/F) | Part A and B | Up to Day 60 | |
| Primary | Absolute bioavailability (F) | Part A | Up to Day 15 | |
| Secondary | Number of participants with Adverse Events | Part A and B | Up to Day 60 | |
| Secondary | Number of participants with Serious Adverse Events | Part A and B | Up to Day 60 | |
| Secondary | Number of participants with AEs leading to discontinuation | Part A and B | Up to Day 60 | |
| Secondary | Number of participants with Vital sign abnormalities | Part A and B | Up to Day 60 | |
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Part A and B | Up to Day 60 | |
| Secondary | Number of participants with physical examination abnormalities | Part A and B | Up to Day 60 | |
| Secondary | Number of participants with clinical laboratory abnormalities | Part A and B | Up to Day 60 |
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