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Completed

NCT Number: NCT00487136

Interaction Between ABT-335, Rosuvastatin and Warfarin

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site Ref # / Investigator 5290

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Warfarin

Drug

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

warfarin plus ABT-335 plus rosuvastatin 5 mg

Drug

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

warfarin plus ABT-335 plus rosuvastatin 20 mg

Drug

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

Primary outcomes

  1. Pharmacokinetic parameters, pharmacodynamic variables

    Time frame: Day 24

Secondary outcomes

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

    Time frame: Day 29

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 15, 2007
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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