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Completed

NCT Number: NCT03712540

An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants

The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.

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Key information

Conditions

Healthy Participants

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Science KK

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening

Exclusion criteria

  • Women who are of childbearing potential or breastfeeding
  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
  • History of significant cardiovascular disease
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986278

Drug

Oral administration 30 mg

Rifampin

Drug

Oral administration 600 mg

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) for BMS-986278

    Time frame: Day 1 and 8

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278

    Time frame: Up to 24 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278

    Time frame: Day 1 and 8

  4. Terminal phase half-life (T-HALF) for BMS-986278

    Time frame: Day 1 and 8

Secondary outcomes

  1. Incidence of non-serious adverse events (AE)

    Time frame: Up to 24 days

  2. Incidence of serious adverse events (SAE)

    Time frame: Up to 24 days

  3. Incidence of AE leading to discontinuation

    Time frame: Up to 24 days

  4. Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests

    Time frame: Up to 24 days

  5. Maximum observed plasma concentration (Cmax) for Rifampin

    Time frame: Day 8

  6. Time of maximum observed plasma concentration (Tmax) for Rifampin

    Time frame: Day 8

  7. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin

    Time frame: Day 8-9

  8. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin

    Time frame: Day 8-9

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Drug-Drug Interaction Study to Assess the Effect of Rifampin on the Pharmacokinetics of an Oral Dose of BMS-986278 in Healthy Participants

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2018
Registry last updated
Jun 12, 2019

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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