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Completed

NCT Number: 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)

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.

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Key information

Conditions

Healthy Participants Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles, Inc, Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986278

Drug

Specified dose on specified days

Sildenafil

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

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

    Time frame: Up to 16 days

  2. Maximum observed plasma concentration (Cmax) (Part 2)

    Time frame: Up to 14 days

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

    Time frame: 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)

    Time frame: Up to 14 days

Secondary outcomes

  1. Cmax (Part 1 and 2)

    Time frame: Up to 16 days

  2. Tmax (Part 1)

    Time frame: Up to 16 days

  3. AUC(0-T) (Part 1)

    Time frame: Up to 16 days

  4. Number of participants with adverse events (AEs) (Part 1 and 2)

    Time frame: 30 days after last dose

  5. Number of participants with serious adverse events (SAEs) (Part 1 and 2)

    Time frame: 30 days after last dose

  6. Number of participants with clinical laboratory abnormalities (Part 1 and 2)

    Time frame: 30 days after last dose

  7. Number of participants with physical examination abnormalities (Part 1 and 2)

    Time frame: 30 days after last dose

  8. Number of participants with vital sign abnormalities (Part 1 and 2)

    Time frame: 30 days after last dose

  9. Number of participants with electrocardiogram (ECG) abnormalities (Part 1 and 2)

    Time frame: 30 days after last dose

  10. Mean placebo-corrected change in diastolic blood pressure (DBP) (Part 1)

    Time frame: 30 days after last dose

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

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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