Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Study Details
Study Description
Brief Summary
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pitavastatin Healthy adult subjects |
Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Names:
Drug: Lopinavir/ritonavir
lopinavir/ritonavir 800 mg/200 mg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Austin | Texas | United States |
Sponsors and Collaborators
- Kowa Research Institute, Inc.
Investigators
- Study Director: Roger Morgan, MD, FACS, Kowa Research Institute, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NK-104-4.02US
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 24 |
| COMPLETED | 23 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | |
| Overall Participants | 24 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
24
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
33.8
(8.24)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
12
50%
|
| Male |
12
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
24
100%
|
Outcome Measures
| Title | Area Under the Curve From Time 0 to Tau (AUC 0-τ) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | |
| Measure Participants | 23 |
| Mean (Standard Deviation) [ng•h/mL] |
113.92
(53.80)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Subjects | |
| Arm/Group Description | ||
All Cause Mortality |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 18/24 (75%) | |
| Gastrointestinal disorders | ||
| Diarrhea | 13/24 (54.2%) | |
| Abdominal pain | 10/24 (41.7%) | |
| Nausea | 8/24 (33.3%) | |
| Anal hemorrhage | 4/24 (16.7%) | |
| Flatulence | 4/24 (16.7%) | |
| Dyspepsia | 3/24 (12.5%) | |
| Constipation | 2/24 (8.3%) | |
| Nervous system disorders | ||
| Headache | 6/24 (25%) | |
| Dysgeusia | 3/24 (12.5%) | |
| Dizziness | 2/24 (8.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Oropharyngeal pain | 3/24 (12.5%) | |
| Rhinorrhea | 2/24 (8.3%) | |
| Skin and subcutaneous tissue disorders | ||
| Dermatitis contact | 3/24 (12.5%) | |
| Rash macular | 2/24 (8.3%) | |
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-104-4.02US