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

NCT ID: NCT02074358

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-04-30

Brief Summary

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

Conditions

Anticoagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment A: Apixaban + Placebo (Saline solution)

Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by Saline solution (placebo) 0 IU/kg infusion for 30 min Intravenously

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Placebo (Saline solution)

Intervention Type: DRUG

Treatment B: Apixaban + Cofact (4-Factor PCC)

Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by a Cofact (4-Factor PCC) 50 IU/kg infusion for 30 min Intravenously

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Cofact (4-Factor PCC)

Intervention Type: DRUG

Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)

Apixaban 10 mg Tablet orally \[Day 1-Day 3: twice daily (BID), Day 4: Single Dose (SD)\] followed 3hr later by a Beriplex P/N (4-Factor PCC) 50 IU/kg infusion for 30 min Intravenously

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Beriplex P/N (4-Factor PCC)

Intervention Type: DRUG

Interventions

Apixaban

Intervention Type: DRUG

Cofact (4-Factor PCC)

Intervention Type: DRUG

Beriplex P/N (4-Factor PCC)

Intervention Type: DRUG

Placebo (Saline solution)

Intervention Type: DRUG

Other Intervention Names

BMS-562247

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

2013-000646-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV185-156

Identifier Type: -

Identifier Source: org_study_id