A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Apixaban; Pharmaceutical Solutions; Thrombin

Criteria

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Inclusion Criteria:

• Healthy subjects

• Body Mass Index (BMI) of 18 to 30 kg/m2

• Ages 18 to 45 years, including

• Women of childbearing potential (WOCBP) on acceptable contraception and with negative pregnancy test and not breastfeeding

Exclusion Criteria:

• History or evidence of coagulopathy

• History or evidence of thrombosis such as deep vein thrombosis or other thromboembolic disease or having a first degree relative under 50 years of age with a history of thromboembolic disease

• Any significant acute or chronic medical illness or relevant trauma

• Any major surgery within 4 weeks of dosing (prior to dosing) or planned within 2 weeks after completion of the study

• History of heavy menstrual bleeding that has produced anemia within the past 1 year

• Current symptomatic or recent gastrointestinal disease or surgery that could impact the absorption of study drug

• History of smoking within 1 month prior to dosing

• Recent history (within 6 months of dosing) of pregnancy

• Use of hormonal contraceptives

• Exposure to any investigational drug or placebo within 4 weeks of study drug administration

• Use of any agent, including but not limited to Aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDs), Anticoagulants, Fish oil capsules, Gingko, etc, that are known to increase the potential for bleeding, within 2 weeks prior to dosing

• History of any severe drug allergy including allergy to Heparin or history of Heparin-induced thrombocytopenia, hypersensitivity to PCCs or Factor Xa inhibitors, or history of allergy to human blood plasma derived products; history of any adverse drug reaction to Anticoagulants or Antiplatelet agents that resulted in excessive bleeding requiring medical intervention