Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: N/A - Healthy Subjects
Intervention: Apixaban (Drug); Atenolol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
Official title: Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Apixaban and Atenolol plasma concentration
Secondary outcome: Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Bms Clinical Research Center, Hamilton, New Jersey 08690, United States
Additional Information
Starting date: June 2007
Last updated: August 6, 2015
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