Interaction Between ABT-335, Rosuvastatin and Warfarin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: warfarin plus ABT-335 plus rosuvastatin 20 mg; Drug: Warfarin; Drug: warfarin plus ABT-335 plus rosuvastatin 5 mg

• Registration Number: NCT00487136
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-15
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warfarin plus ABT-335 mg plus rosuvastatin 20 mg	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.
Warfarin	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.
Warfarin plus ABT-335 plus Rosuvastatin	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters, pharmacodynamic variables	Day 24

Secondary Outcome Measures

Name	Time	Method
Vital signs, physical examinations, laboratory tests, ECGs, adverse events	Day 29

Trial Locations

Locations (1)

Site Ref # / Investigator 5290; 🇺🇸 Little Rock, Arkansas, United States