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Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects

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: NCT00996879
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 14, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date May 6, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Pharmacokinetics parameters area under curve (AUC) (TAU), maximum concentration (Cmax) [ Time Frame: Within 24 hours of dosing ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examination and clinical laboratory tests [ Time Frame: On Days 1, 2, 4, 6, 8, 9, and 10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects
Official Title  ICMJE Study to Evaluate the Effect of BMS-791325 on the Pharmacokinetics of the CYP3A4 Probe Midazolam Administered Orally in Healthy Subjects
Brief Summary The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of the CYP3A4 Probe Midazolam.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Midazolam
    Syrup, Oral, 5 mg, Single dose, 2 days
  • Drug: BMS-791325
    Capsules, Oral, 300 mg, Every 12 hours, 8 days
Study Arms  ICMJE Experimental: Midazolam + BMS-791325
Interventions:
  • Drug: Midazolam
  • Drug: BMS-791325
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2013)
48
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
14
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female subjects aged 18 to 49 years, with BMI of 18-32 kg/m²
  • Women who are not of childbearing potential

Exclusion Criteria:

  • Women of childbearing potential
  • Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
  • Gastrointestinal disease that may impact the absorption of study drug
  • History of any chronic respiratory disease (asthma, COPD)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996879
Other Study ID Numbers  ICMJE AI443-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP