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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: BMS-986278; Drug: Sildenafil

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Altasciences Clinical Los Angeles, Inc
  • Florida
    • Miami, Florida, United States, 33136
      • Syneos Health Clinical Research Services, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Sildenafil; Idiopathic Pulmonary Fibrosis (IPF); BMS-986278
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: IM027-1017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No