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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03712540
Collaborator
(none)
39
Enrollment
1
Location
1
Arm
2.1
Actual Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
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 :
Sep 6, 2018
Actual Primary Completion Date :
Nov 8, 2018
Actual Study Completion Date :
Nov 8, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) for BMS-986278 [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 [Up to 24 days]

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278 [Day 1 and 8]

  4. Terminal phase half-life (T-HALF) for BMS-986278 [Day 1 and 8]

Secondary Outcome Measures

  1. Incidence of non-serious adverse events (AE) [Up to 24 days]

  2. Incidence of serious adverse events (SAE) [Up to 24 days]

  3. Incidence of AE leading to discontinuation [Up to 24 days]

  4. Incidence of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests [Up to 24 days]

  5. Maximum observed plasma concentration (Cmax) for Rifampin [Day 8]

  6. Time of maximum observed plasma concentration (Tmax) for Rifampin [Day 8]

  7. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for Rifampin [Day 8-9]

  8. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for Rifampin [Day 8-9]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Science KK Lenexa Kansas United States 66219

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03712540
Other Study ID Numbers:
  • IM027-017
First Posted:
Oct 19, 2018
Last Update Posted:
Jun 12, 2019
Last Verified:
Jun 1, 2019
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rifampin

Study Results

No Results Posted as of Jun 12, 2019