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

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ClinicalTrials.gov Identifier: NCT03712540
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986278 Drug: Rifampin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 6, 2018
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: BMS-986278 + Rifampin
Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278
Drug: BMS-986278
Oral administration 30 mg

Drug: Rifampin
Oral administration 600 mg




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712540


Locations
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United States, Kansas
PRA Health Science KK
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03712540     History of Changes
Other Study ID Numbers: IM027-017
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers