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
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study. Each subject will qualify for entry into the study not more than 30 days before admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be 1 treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 12 through 16 and a once daily dose of darunavir/ritonavir 800 mg/100 mg on Days 6 through 16. On Days 1 through 4, 6 through 10, and 12 through 15, study drug will be administered 30 minutes before a standard breakfast. On Days 5, 11, and 16, subjects will fast at least 8 hours before receiving study drug and remain fasted for 4 hours after dosing.
Interventions
Pitavastatin (NK-104) 4mg once daily (QD)
DRUGDarunavir/Ritonavir (Prezista)
Darunavir/Ritonavir (Prezista) 800 mg/100 mg
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, caffeine or caffeine containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until completion of the study * Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until 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, darunavir, ritonavir, sulfonamides, 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 | 16 Days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With at Least One Adverse Event. | 16 Days |
Countries
United States
Participant flow
Recruitment details
1st Subject Enrolled 20 April 2011 Last Subject Completed 10 June 2011
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All randomized subjects | 28 |
| Total | 28 |
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 | 30.5 years STANDARD_DEVIATION 6.61 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
NK-104 AUC
Time frame: 16 Days
Population: All subjects with measurable pharmacokinetic (PK) values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NK-104 | NK-104 AUC | 192.00 ng * h/mL | Standard Deviation 80.8 |
Secondary
Number of Participants With at Least One Adverse Event.
Time frame: 16 Days
Population: All subjects who took at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NK-104 | Number of Participants With at Least One Adverse Event. | 2 Participants |