Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563950
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Rifampin Drug: BMS-986224 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Rifampin + BMS-986224
Oral administration
 Drug: Rifampin
Specified dose on specified days

Drug: BMS-986224
Specified dose on specified days


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986224 [ Time Frame: 5 days ]
  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224 [ Time Frame: 5 days ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224 [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Biomarker plasma concentrations of BMS-986224 [ Time Frame: 5 days ]
  2. Time of maximum observed plasma concentration (Tmax) of BMS-986224 [ Time Frame: 5 days ]
  3. Terminal elimination half-life (T-HALF) of BMS-986224 [ Time Frame: 5 days ]
  4. Metabolite of BMS-986224 Cmax [ Time Frame: 5 days ]
  5. Metabolite of BMS-986224 AUC(0-T) [ Time Frame: 5 days ]
  6. Metabolite of BMS-986224 AUC(INF) [ Time Frame: 5 days ]
  7. Incidence of nonserious adverse events (AE) [ Time Frame: 17 days ]
  8. Incidence of serious adverse events (SAE) [ Time Frame: 30 days ]
  9. Incidence of AEs leading to discontinuation [ Time Frame: 17 days ]
  10. Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests [ Time Frame: 18 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (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:

  • Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

  • Women of childbearing potential
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy

Other protocol defined inclusion/exclusion criteria may apply

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03563950


Locations
Layout table for location information
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03563950    
Other Study ID Numbers: CV016-008
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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