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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 9, 2010
Last Updated Date	September 6, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 6, 2012)	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)
Original Primary Outcome Measures ^ICMJE (submitted: August 9, 2010)	pharmacodynamics of warfarin by measuring any effect on INR and PT. [ Time Frame: Seven Days ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01178853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Pitavastatin/Rosuvastatin Interventions: Drug: Warfarin Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD) Experimental: Rosuvastatin/Pitavastatin Interventions: Drug: Warfarin Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	April 2011
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01178853
Other Study ID Numbers ^ICMJE	NK-104-4.03US
Has Data Monitoring Committee	No
Responsible Party	Kowa Research Institute, Inc.
Study Sponsor ^ICMJE	Kowa Research Institute, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kowa Research Institute, Inc.
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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