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

NCT01178853 | Completed Phase 4 Results

• 1 other identifier: NK-104-4.03US
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Percent Mean Change From Baseline of International Normalized Ratio (INR)

  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)

  22 Days

Study Arms (2)

Pitavastatin/Rosuvastatin

EXPERIMENTAL

Drug: Warfarin; Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)

Rosuvastatin/Pitavastatin

EXPERIMENTAL

Drug: Warfarin; Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD); Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)

Interventions

Warfarin DRUG

Warfarin 5 mg once daily

Pitavastatin/Rosuvastatin; Rosuvastatin/Pitavastatin

Warfarin 5mg + Rosuvastatin 40 mg once daily (QD) DRUG

Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)

Pitavastatin/Rosuvastatin; Rosuvastatin/Pitavastatin

Warfarin 5 mg + Pitavastatin 4mg once daily (QD) DRUG

Warfarin 5 mg + Pitavastatin 4mg

Pitavastatin/Rosuvastatin; Rosuvastatin/Pitavastatin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Interventions

Warfarin; Rosuvastatin Calcium; pitavastatin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Roger Morgan, MD, FACS
• Organization: Kowa Research Institute, Inc.

RMorgan@KowaUS.com

919-433-1600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: October 8, 2012
• Results First Posted: October 8, 2012

Record last verified: 2012-09

Locations

US (1)