Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01178853
First received: August 9, 2010
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.


Condition Intervention Phase
Healthy
Drug: Warfarin
Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • Percent Mean Change From Baseline of International Normalized Ratio (INR) [ Time Frame: 22 Days ] [ Designated as safety issue: Yes ]
    INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)


Enrollment: 48
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin/Rosuvastatin Drug: Warfarin
Warfarin 5 mg once daily
Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg
Experimental: Rosuvastatin/Pitavastatin Drug: Warfarin
Warfarin 5 mg once daily
Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive
  • Subject has a body mass index of 18 to 32 kg/m2, inclusive
  • Subject is able and willing to abstain from alcohol, grapefruit, caffeine
  • Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs

Exclusion Criteria:

  • Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S
  • Subject has abnormal prolongation of bleeding time at Screening
  • Subject has hematuria on urinalysis
  • Subject has personal or family history of coagulation or bleeding disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178853

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
  More Information

No publications provided

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01178853     History of Changes
Other Study ID Numbers: NK-104-4.03US
Study First Received: August 9, 2010
Results First Received: March 29, 2012
Last Updated: September 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers

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

ClinicalTrials.gov processed this record on April 17, 2014