Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04301310
Collaborator
(none)
0
1
1
7
0

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.

Condition or Disease Intervention/Treatment Phase
  • Drug: BMS-986235 (Treatment A)
  • Drug: Rifampin (Treatment B)
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety, and Tolerability of BMS-986235 in Healthy Participants
Actual Study Start Date :
Mar 9, 2020
Actual Primary Completion Date :
Mar 16, 2020
Actual Study Completion Date :
Mar 16, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Drug: BMS-986235 (Treatment A)
Specified dose on specified days

Drug: Rifampin (Treatment B)
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Maximum plasma concentration (Cmax) of BMS-986235 [Day 1]

  2. Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 [Day 1]

  3. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 [Day 1]

  4. Cmax of BMS-986235 with rifampin [Day 10]

  5. AUC(0-T) of BMS-986235 with rifampin [Day 10]

  6. AUC(INF) of BMS-986235 with rifampin [Day 10]

Secondary Outcome Measures

  1. Incidence of Nonserious Adverse Events (AEs) [Up to 46 days]

  2. Incidence of Serious Adverse Events (SAEs) [Up to 74 days]

  3. Incidence of AEs leading to discontinuation [Up to 13 days]

  4. Incidence of clinically significant changes from baseline in physical examination findings [Up to 41 days]

  5. Incidence of clinically significant changes in vital signs: Body temperature [Up to 41 days]

  6. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 41 days]

  7. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 41 days]

  8. Incidence of clinically significant changes in vital signs: Heart rate [Up to 41 days]

  9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 41 days]

  10. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 41 days]

  11. Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests [Up to 41 days]

  12. Incidence of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2)) [Up to 41 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 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:
  • Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.

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

  • Males must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:
  • Women of childbearing potential (WOCBP)

  • Known previous exposure to BMS-986235

  • History of any significant drug allergy

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Local Institution Salt Lake City Utah United States 84124

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:
NCT04301310
Other Study ID Numbers:
  • CV018-023
First Posted:
Mar 10, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022