Healthy
Conditions
Keywords
Healthy Volunteers
Brief summary
This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.
Interventions
DRUGWarfarin
Warfarin 5 mg once daily
DRUGWarfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
DRUGWarfarin 5 mg + Pitavastatin 4mg once daily (QD)
Warfarin 5 mg + Pitavastatin 4mg
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
14 July 2010 - 09 November 2010
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin/Rosuvastatin | 24 |
| Rosuvastatin/Pitavastatin | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Warfarin Titration) | INR Out of Range | 1 | 2 |
| Period 2 (Warfarin + Study Drug) | Withdrawal by Subject | 1 | 0 |
| Period 3 (Warfarin Titration) | Adverse Event | 1 | 0 |
| Period 4 (Warfarin + Study Drug) | Adverse Event | 0 | 2 |
| Period 4 (Warfarin + Study Drug) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Rosuvastatin/Pitavastatin | Pitavastatin/Rosuvastatin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48 Participants |
| Age Continuous | 34.1 years STANDARD_DEVIATION 7.2 | 32.4 years STANDARD_DEVIATION 7.8 | 33.3 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 24 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 42 | 3 / 43 |
| serious Total, serious adverse events | 0 / 42 | 0 / 43 |
Outcome results
Primary
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)
Time frame: 22 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin + Pitavastatin | Percent Mean Change From Baseline of International Normalized Ratio (INR) | 0.0452 percent change | Standard Deviation 2.61 |
| Warfarin + Rosuvastatin | Percent Mean Change From Baseline of International Normalized Ratio (INR) | 0.1605 percent change | Standard Deviation 9.43 |