Interaction Between ABT-335, Rosuvastatin and Warfarin

AstraZeneca45 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

WarfarinDRUG

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 5 mgDRUG

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.

warfarin plus ABT-335 plus rosuvastatin 20 mgDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Site Ref # / Investigator 5290

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters, pharmacodynamic variables

Time frame: Day 24

Secondary Outcomes

Vital signs, physical examinations, laboratory tests, ECGs, adverse events

Time frame: Day 29

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.