Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
Brief summary
This is a Phase 4, single center, open label, fixed-sequence, 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 prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.
Interventions
pitavastatin (NK-104) 4 mg once daily (QD)
DRUGLopinavir/ritonavir
lopinavir/ritonavir 800 mg/200 mg
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
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 for 4 days before Day 1 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.
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 or lopinavir/ritonavir. * 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 | Description |
|---|---|---|
| Area Under the Curve From Time 0 to Tau (AUC 0-τ) | 0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24 | Area under the curve from start to elimination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 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 | 24 Participants |
| Age, Continuous | 33.8 years STANDARD_DEVIATION 8.24 |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Area Under the Curve From Time 0 to Tau (AUC 0-τ)
Area under the curve from start to elimination.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects | Area Under the Curve From Time 0 to Tau (AUC 0-τ) | 113.92 ng•h/mL | Standard Deviation 53.8 |