A Study Investigating the Safety, Tolerability, Drug Levels and Drug Effect of BMS-986278 in Healthy Adult Participants (Part 1) and Japanese Participants (Part 2)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986278
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: BMS-986278 + Sildenafil<br> | Drug: BMS-986278<br>* Specified dose on specified days<br>Drug: Sildenafil<br>* Specified dose on specified days<br>|
| Placebo Comparator: Part 1: Placebo + Sildenafil<br> | Drug: Sildenafil<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Part 2: BMS-986278<br> | Drug: BMS-986278<br>* Specified dose on specified days<br>|
| Placebo Comparator: Part 2: Placebo<br> | Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Part 1 and 2) |  | Up to 16 days | 
| Tmax (Part 1) |  | Up to 16 days | 
| AUC(0-T) (Part 1) |  | Up to 16 days | 
| Number of participants with adverse events (AEs) (Part 1 and 2) |  | 30 days after last dose | 
| Number of participants with serious adverse events (SAEs) (Part 1 and 2) |  | 30 days after last dose | 
| Number of participants with clinical laboratory abnormalities (Part 1 and 2) |  | 30 days after last dose | 
| Number of participants with physical examination abnormalities (Part 1 and 2) |  | 30 days after last dose | 
| Number of participants with vital sign abnormalities (Part 1 and 2) |  | 30 days after last dose | 
| Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2) |  | 30 days after last dose | 
| Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1) |  | 30 days after last dose | 
| Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2) |  | Up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986278, Idiopathic Pulmonary Fibrosis (IPF), Sildenafil