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BIBR 1048 MS dose 5 refers to the 400 mg dose level (dose group 5) of dabigatran etexilate mesylate (BIBR 1048 MS) administered as an oral drinking solution in a first-in-human, single ascending dose Phase 1 clinical study. Developed by Boehringer Ingelheim, dabigatran etexilate is an orally active prodrug that is rapidly converted in vivo to dabigatran (BIBR 953 ZW), a potent, nonpeptidic direct thrombin inhibitor. Dabigatran reversibly binds to the active site of both free and clot-bound thrombin, preventing thrombin-mediated coagulation and platelet aggregation. This specific dose cohort was evaluated in healthy male subjects to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug for the prevention and treatment of thromboembolic conditions, such as venous thromboembolism and stroke in patients with atrial fibrillation.
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