Healthy
Conditions
Keywords
Healthy Volunteers
Brief summary
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.
Detailed description
Each subject will qualify for entry into the study not more than 30 days prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. During the treatment period, each subject will receive a once-daily dose of pitavastatin 4 mg on Days 1 through 5 and on Days 11 through 15 and a once-daily dose of diltiazem 240 mg on Days 6 through 15. Subjects will fast overnight for at least 8 hours before dosing and will remain fasted until 4 hours after dosing on the morning of Days 5, 10, and 15.
Interventions
pitavastatin (NK-104) 4 mg once daily (QD)
DRUGDiltiazem (Cardizem LA) 240 mg QD
Diltiazem (Cardizem LA) 240 mg QD
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male or female volunteer aged 18 to 45 years, inclusive. * Subject has a body mass index of 18 to 30 kg/m2, inclusive. * Subject has normal hematology, serum chemistry, and urinalysis test results. * Subject is able and willing to abstain from alcohol, grapefruit-containing foods or beverages, caffeine, or caffeine-containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until after completion of this study. * Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until after study completion.
Exclusion criteria
* Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion. * Subject has had a previous allergy or intolerance to treatment with pitavastatin, diltiazem, or any drugs in these classes. * Subject has a history of drug or alcohol abuse. * Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK-104 AUC | 15 Days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With at Least One Adverse Event. | 24 Days |
Countries
United States
Participant flow
Recruitment details
1st Subject Enrolled 05 May 2011, Last Subject Completed 12 July 2011 at PPD Inc. 7551 Metro Center Drive Suite 200 Austin, TX 78744
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All randomized subjects. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| NK-104 4mg QD and Diltiazem 240 mg QD | personal reasons | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 29.2 years STANDARD_DEVIATION 7.63 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
NK-104 AUC
Time frame: 15 Days
Population: All subjects with measurable pharmacokinetic (PK) values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | NK-104 AUC | 208.92 ng * h/mL | Standard Deviation 86.54 |
Secondary
Number of Participants With at Least One Adverse Event.
Time frame: 24 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects | Number of Participants With at Least One Adverse Event. | 12 Participants |