Interaction Between ABT-335, Rosuvastatin and Warfarin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00487136
First received: June 13, 2007
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multiple-Dose Pharmacokinetic and Pharmacodynamic Interaction Between ABT-335, Rosuvastatin and Warfarin

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pharmacokinetic parameters, pharmacodynamic variables [ Time Frame: Day 24 ]

Secondary Outcome Measures:
  • Vital signs, physical examinations, laboratory tests, ECGs, adverse events [ Time Frame: Day 29 ]

Enrollment: 45
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Warfarin
  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487136

Locations
United States, Arkansas
Site Ref # / Investigator 5290
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00487136     History of Changes
Other Study ID Numbers: M06-887
Study First Received: June 13, 2007
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Drug Interaction
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Warfarin
Fenofibric acid
Rosuvastatin
Fenofibrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014