Interaction Between ABT-335, Rosuvastatin and Warfarin

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Warfarin
* Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg
* Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Warfarin<br>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<br>* 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.<br>* Other names: Coumadin;|
| Experimental: Warfarin plus ABT-335 plus Rosuvastatin<br>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<br>* 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.<br>* Other names: Crestor;|
| Experimental: Warfarin plus ABT-335 mg plus rosuvastatin 20 mg<br>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<br>* 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.<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters, pharmacodynamic variables |  | Day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs, physical examinations, laboratory tests, ECGs, adverse events |  | Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Interaction, Pharmacokinetics, Pharmacodynamics