A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)
- Registration Number
- NCT01379300
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rivaroxaban rivaroxaban Single 20-mg dose of rivaroxaban Dabigatran dabigatran etexilate Single 150-mg dose of dabigatran etexilate
- Primary Outcome Measures
Name Time Method Level of fibrinopeptide A (FPA) From up to 2 hours pre-dose to up to 24 hours post-dose Level of thrombin-antithrombin complex (TAT) From up to 2 hours pre-dose to up to 24 hours post-dose Level of fibrin degradation product (D-dimer) From up to 2 hours pre-dose to up to 24 hours post-dose Level of prothrombin split products (F1+2) From up to 2 hours pre-dose to up to 24 hours post-dose Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay From up to 2 hours pre-dose to up to 24 hours post-dose
- Secondary Outcome Measures
Name Time Method