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)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05684289
• Collaborator: (none)
• Enrollment: 60
• Arms: 4
• Anticipated Duration (Months): 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986278; Drug: Sildenafil; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Anticipated Study Start Date: Jan 3, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1) [Up to 16 days]

2. Maximum observed plasma concentration (Cmax) (Part 2) [Up to 14 days]

3. Time of maximum observed plasma concentration (Tmax) (Part 2) [Up to 14 days]

4. 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

1. Cmax (Part 1 and 2) [Up to 16 days]

2. Tmax (Part 1) [Up to 16 days]

3. AUC(0-T) (Part 1) [Up to 16 days]

4. Number of participants with adverse events (AEs) (Part 1 and 2) [30 days after last dose]

5. Number of participants with serious adverse events (SAEs) (Part 1 and 2) [30 days after last dose]

6. Number of participants with clinical laboratory abnormalities (Part 1 and 2) [30 days after last dose]

7. Number of participants with physical examination abnormalities (Part 1 and 2) [30 days after last dose]

8. Number of participants with vital sign abnormalities (Part 1 and 2) [30 days after last dose]

9. Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2) [30 days after last dose]

10. Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1) [30 days after last dose]

11. Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2) [Up to 14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05684289
• Other Study ID Numbers: IM027-1017
• First Posted: Jan 13, 2023
• Last Update Posted: Jan 13, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: BMS-986278; Idiopathic Pulmonary Fibrosis (IPF); Sildenafil
• Additional relevant MeSH terms: Sildenafil Citrate

Study Results

No Results Posted as of Jan 13, 2023