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
Study Details
Study Description
Brief Summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Percent Mean Change From Baseline of International Normalized Ratio (INR) [22 Days]
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)
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Austin | Texas | United States |
Sponsors and Collaborators
- Kowa Research Institute, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NK-104-4.03US
Study Results
Participant Flow
| Recruitment Details | 14 July 2010 - 09 November 2010 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pitavastatin/Rosuvastatin | Rosuvastatin/Pitavastatin |
|---|---|---|
| Arm/Group Description | ||
| Period Title: Period 1 (Warfarin Titration) | ||
| STARTED | 24 | 24 |
| COMPLETED | 23 | 22 |
| NOT COMPLETED | 1 | 2 |
| Period Title: Period 1 (Warfarin Titration) | ||
| STARTED | 23 | 22 |
| COMPLETED | 22 | 22 |
| NOT COMPLETED | 1 | 0 |
| Period Title: Period 1 (Warfarin Titration) | ||
| STARTED | 22 | 22 |
| COMPLETED | 21 | 22 |
| NOT COMPLETED | 1 | 0 |
| Period Title: Period 1 (Warfarin Titration) | ||
| STARTED | 21 | 22 |
| COMPLETED | 21 | 19 |
| NOT COMPLETED | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Pitavastatin/Rosuvastatin | Rosuvastatin/Pitavastatin | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Participants | 24 | 24 | 48 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
24
100%
|
24
100%
|
48
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
32.4
(7.8)
|
34.1
(7.2)
|
33.3
(7.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
33.3%
|
8
33.3%
|
16
33.3%
|
| Male |
16
66.7%
|
16
66.7%
|
32
66.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
24
100%
|
24
100%
|
48
100%
|
Outcome Measures
| Title | Percent Mean Change From Baseline of International Normalized Ratio (INR) |
|---|---|
| Description | 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) |
| Time Frame | 22 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Warfarin + Pitavastatin | Warfarin + Rosuvastatin |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 42 | 43 |
| Mean (Standard Deviation) [percent change] |
0.0452
(2.61)
|
0.1605
(9.43)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Warfarin + Pitavastatin | Warfarin + Rosuvastatin | ||
| Arm/Group Description | ||||
All Cause Mortality |
||||
| Warfarin + Pitavastatin | Warfarin + Rosuvastatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Warfarin + Pitavastatin | Warfarin + Rosuvastatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/43 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Warfarin + Pitavastatin | Warfarin + Rosuvastatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/42 (14.3%) | 3/43 (7%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 3/42 (7.1%) | 3/43 (7%) | ||
| Nervous system disorders | ||||
| Headache | 3/42 (7.1%) | 0/43 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
May not publish
Results Point of Contact
| Name/Title | Roger Morgan, MD, FACS |
|---|---|
| Organization | Kowa Research Institute, Inc. |
| Phone | 919-433-1600 |
| RMorgan@KowaUS.com |
- NK-104-4.03US