Clinical trial

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)

Name
IM027-1017
Description
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.
Trial arms
Trial start
2023-01-03
Estimated PCD
2023-05-02
Trial end
2023-05-02
Status
Completed
Phase
Early phase I
Treatment
BMS-986278
Specified dose on specified days
Arms:
Part 1: BMS-986278 + Sildenafil, Part 2: BMS-986278
Sildenafil
Specified dose on specified days
Arms:
Part 1: BMS-986278 + Sildenafil, Part 1: Placebo + Sildenafil
Placebo
Specified dose on specified days
Arms:
Part 1: Placebo + Sildenafil, Part 2: Placebo
Size
61
Primary endpoint
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
Up to 16 days
Maximum observed plasma concentration (Cmax) (Part 2)
Up to 14 days
Time of maximum observed plasma concentration (Tmax) (Part 2)
Up to 14 days
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
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 61, 'type': 'ACTUAL'}}
Updated at
2023-08-24

1 organization

3 products

1 indication

Product
BMS-986278
Product
Placebo
Product
Sildenafil