Interaction Between ABT-335, Rosuvastatin and Warfarin

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00487136

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

45.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multiple-dose, double-blind, randomized, single-center, parallel-group study in adult male subjects in general good health.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Warfarin Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Warfarin Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.	Drug: Warfarin Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days. Other Names: Coumadin
Experimental: Warfarin plus ABT-335 plus Rosuvastatin Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.	Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days. Other Names: warfarin coumadin ABT-335 fenofibric acid Trilipix Rosuvastatin Crestor
Experimental: Warfarin plus ABT-335 mg plus rosuvastatin 20 mg Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.	Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days. Other Names: warfarin coumadin ABT-335 fenofibric acid Trilipix Rosuvastatin Crestor

Arm

Intervention/Treatment

Active Comparator: Warfarin

Warfarin fixed dose plus one capsule containing placebo for ABT-335, one placebo tablet to match rosuvastatin 5 mg and one placebo tablet to match rosuvastatin 20 mg, administered for 10 consecutive days.

Drug: Warfarin

Other Names:

Coumadin

Experimental: Warfarin plus ABT-335 plus Rosuvastatin

Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one 5 mg tablet of rosuvastatin and one tablet of placebo to match rosuvastatin 20 mg, administered for 10 consecutive days.

Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg

Other Names:

warfarin

coumadin ABT-335

fenofibric acid

Trilipix Rosuvastatin

Crestor

Experimental: Warfarin plus ABT-335 mg plus rosuvastatin 20 mg

Warfarin fixed dose plus one capsule containing ABT-335 mini-tablets equivalent to 135 mg fenofibric acid, one tablet of placebo to match rosuvastatin 5 mg and one 20 mg tablet of rosuvastatin, administered for 10 consecutive days.

Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg

Other Names:

warfarin

coumadin

ABT-335

fenofibric acid

Trilipix Rosuvastatin

Crestor

Outcome Measures

Primary Outcome Measures

Pharmacokinetic parameters, pharmacodynamic variables [Day 24]

Secondary Outcome Measures

Vital signs, physical examinations, laboratory tests, ECGs, adverse events [Day 29]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Body mass index (BMI) is 19 to 29, inclusive.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Written informed consent prior to the initiation of screening or study-specific procedures.

Exclusion Criteria:

Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
Subjects taking concomitant medications.
Subjects with a recent history of surgery or trauma.
Subjects with a history of any bleeding disorder.