Clinical Trials/NCT05684289

NCT05684289

Completed

Phase 1

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)

Bristol-Myers Squibb2 sites in 1 country61 target enrollmentJanuary 3, 2023

ConditionsHealthy Participants

InterventionsBMS-986278 Sildenafil Placebo

DrugsBMS-986278 Sildenafil Placebo

Overview

Phase: Phase 1
Intervention: BMS-986278
Conditions: Healthy Participants
Sponsor: Bristol-Myers Squibb
Enrollment: 61
Locations: 2
Primary Endpoint: Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2023

End Date

May 2, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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 \[m\])\^
•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.

Arms & Interventions

Part 1: BMS-986278 + Sildenafil

Intervention: BMS-986278

Part 1: BMS-986278 + Sildenafil

Intervention: Sildenafil

Part 1: Placebo + Sildenafil

Intervention: Sildenafil

Part 1: Placebo + Sildenafil

Intervention: Placebo

Part 2: BMS-986278

Intervention: BMS-986278

Part 2: Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)

Time Frame: Up to 16 days

Time of maximum observed plasma concentration (Tmax) (Part 2)

Time Frame: 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)

Time Frame: Up to 14 days

Maximum observed plasma concentration (Cmax) (Part 2)

Time Frame: Up to 14 days

Secondary Outcomes

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)
AUC(0-T) (Part 1)(Up to 16 days)
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)
Cmax (Part 1 and 2)(Up to 16 days)
Number of participants with physical examination abnormalities (Part 1 and 2)(30 days after last dose)
Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)(Up to 14 days)
Tmax (Part 1)(Up to 16 days)
Number of participants with adverse events (AEs) (Part 1 and 2)(30 days after last dose)