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)

NCT05684289 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1017
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Participants

Keywords

BMS-986278; Idiopathic Pulmonary Fibrosis (IPF); Sildenafil

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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

Study Arms (4)

Part 1: BMS-986278 + Sildenafil

EXPERIMENTAL

Drug: BMS-986278; Drug: Sildenafil

Part 1: Placebo + Sildenafil

PLACEBO COMPARATOR

Drug: Sildenafil; Drug: Placebo

Part 2: BMS-986278

EXPERIMENTAL

Drug: BMS-986278

Part 2: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BMS-986278 DRUG

Specified dose on specified days

Part 1: BMS-986278 + Sildenafil; Part 2: BMS-986278

Sildenafil DRUG

Specified dose on specified days

Part 1: BMS-986278 + Sildenafil; Part 1: Placebo + Sildenafil

Placebo DRUG

Specified dose on specified days

Part 1: Placebo + Sildenafil; Part 2: Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

Syneos Health Clinical Research Services, Llc

Miami, Florida, 33136, United States

Location

Related Links

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

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 13, 2023
• Study Start: January 3, 2023
• Primary Completion: May 2, 2023
• Study Completion: May 2, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)