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Trial record 1 of 1 for:    NCT02262533
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Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02262533
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : August 10, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 9, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date August 10, 2015
Study Start Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Apixaban and Atenolol plasma concentration [ Time Frame: Days 1-13 ]
Blood samples for Atenolol PK were collected on days 1-3 of each period (Treatment B and C). Blood samples for Apixaban PK were collected on days 1-4 of each period (Treatment A and C)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2014)
Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests [ Time Frame: Days 1-13 ]
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 Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Official Title  ICMJE Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Brief Summary The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE N/A - Healthy Subjects
Intervention  ICMJE
  • Drug: Apixaban
  • Drug: Atenolol
Study Arms  ICMJE
  • Experimental: Treatment A: Apixaban
    Apixaban tablet by mouth on specified day
    Intervention: Drug: Apixaban
  • Experimental: Treatment B: Atenolol
    Atenolol tablet by mouth on specified day
    Intervention: Drug: Atenolol
  • Experimental: Treatment C: Apixaban and Atenolol
    Apixaban and Atenolol tablets by mouth on specified day
    Interventions:
    • Drug: Apixaban
    • Drug: Atenolol
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: October 9, 2014)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations

Exclusion Criteria:

  • Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT02262533
Other Study ID Numbers  ICMJE CV185-033
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 Pfizer
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2015

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