A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)

Phase 1

Completed

• Conditions: Thrombosis
• Interventions: Drug: rivaroxaban; Drug: dabigatran etexilate

• 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-21
• Study First Posted: 2011-06-23
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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