Healthy Participants Clinical Trial
Official title:
A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants
The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
| Status | Not yet recruiting |
| Enrollment | 82 |
| Est. completion date | December 10, 2024 |
| Est. primary completion date | November 18, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0001 | Lenexa | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to Day 75 | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] | Up to Day 75 | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Up to Day 75 | ||
| Secondary | To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation | Up to Day 75 | ||
| Secondary | Incidence of adverse events (AE) | Up to Day 75 | ||
| Secondary | Incidence of serious adverse events (SAE) | Up to Day 75 | ||
| Secondary | Number of participants with physical examination abnormalities | Up to Day 75 | ||
| Secondary | Number of participants with vital sign abnormalities | Up to Day 75 | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to Day 75 | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 75 |
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