Clinical trial NCT05684289: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986278
Idiopathic Pulmonary Fibrosis (IPF)
Sildenafil
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 61
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
timeFrame: Up to 16 days
measure: Maximum observed plasma concentration (Cmax) (Part 2)
timeFrame: Up to 14 days
measure: Time of maximum observed plasma concentration (Tmax) (Part 2)
timeFrame: Up to 14 days
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)
timeFrame: Up to 14 days
Secondary outcomes:
measure: Cmax (Part 1 and 2)
timeFrame: Up to 16 days
measure: Tmax (Part 1)
timeFrame: Up to 16 days
measure: AUC(0-T) (Part 1)
timeFrame: Up to 16 days
measure: Number of participants with adverse events (AEs) (Part 1 and 2)
timeFrame: 30 days after last dose
measure: Number of participants with serious adverse events (SAEs) (Part 1 and 2)
timeFrame: 30 days after last dose
measure: Number of participants with clinical laboratory abnormalities (Part 1 and 2)
timeFrame: 30 days after last dose
measure: Number of participants with physical examination abnormalities (Part 1 and 2)
timeFrame: 30 days after last dose
measure: Number of participants with vital sign abnormalities (Part 1 and 2)
timeFrame: 30 days after last dose
measure: Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2)
timeFrame: 30 days after last dose
measure: Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1)
timeFrame: 30 days after last dose
measure: Area under the concentration-time curve in 1 dosing interval (AUC [TAU]) (Part 2)
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
city: Miami
country: United States
facility: Syneos Health Clinical Research Services, Llc
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: