Healthy Participants Clinical Trial
Official title:
A Phase 1, 2-Part, Randomized, Double-Blind, Placebo-controlled, Multiple Dose Study to Test the Potential Interaction of a PDE5 Inhibitor With BMS-986278 and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986278 in Healthy Adult Participants (Part 1) and in Japanese Participants (Part 2)
| Verified date | August 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of BMS-986278 in healthy adult participants and Japanese participants.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | May 2, 2023 |
| Est. primary completion date | May 2, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 35 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Participants in the Japanese cohort (Part 2) must be first generation Japanese (born in Japan, not living outside of Japan > 10 years, both parents ethnically Japanese). - Body mass index (BMI) of 18.0 kilogram (kg)/meter (m)^2 through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2. - Body weight = 50 kg for males and = 45 kg for females. Exclusion Criteria: - Any significant acute or chronic medical illness. - Any gastrointestinal (GI) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. - Any major surgery within 4 weeks of first study intervention administration. Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Altasciences Clinical Los Angeles, Inc | Cypress | California |
| United States | Syneos Health Clinical Research Services, Llc | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1) | Up to 16 days | ||
| Primary | Maximum observed plasma concentration (Cmax) (Part 2) | Up to 14 days | ||
| Primary | Time of maximum observed plasma concentration (Tmax) (Part 2) | Up to 14 days | ||
| Primary | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2) | Up to 14 days | ||
| Secondary | Cmax (Part 1 and 2) | Up to 16 days | ||
| Secondary | Tmax (Part 1) | Up to 16 days | ||
| Secondary | AUC(0-T) (Part 1) | Up to 16 days | ||
| Secondary | Number of participants with adverse events (AEs) (Part 1 and 2) | 30 days after last dose | ||
| Secondary | Number of participants with serious adverse events (SAEs) (Part 1 and 2) | 30 days after last dose | ||
| Secondary | Number of participants with clinical laboratory abnormalities (Part 1 and 2) | 30 days after last dose | ||
| Secondary | Number of participants with physical examination abnormalities (Part 1 and 2) | 30 days after last dose | ||
| Secondary | Number of participants with vital sign abnormalities (Part 1 and 2) | 30 days after last dose | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2) | 30 days after last dose | ||
| Secondary | Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1) | 30 days after last dose | ||
| Secondary | Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2) | Up to 14 days |
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|---|---|---|---|
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