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This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | Experimental | pitavastatin 4 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin (NK-104) | Drug | Pitavastatin (NK-104) 4mg once daily (QD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| NK-104 AUC | 16 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adverse Event. | 16 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Morgan, MD, FACS | Kowa Research Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24825411 | Derived | Yu CY, Campbell SE, Sponseller CA, Small DS, Medlock MM, Morgan RE. Steady-state pharmacokinetics of darunavir/ritonavir and pitavastatin when co-administered to healthy adult volunteers. Clin Drug Investig. 2014 Jul;34(7):475-82. doi: 10.1007/s40261-014-0198-x. |
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1st Subject Enrolled 20 April 2011 Last Subject Completed 10 June 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All randomized subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NK-104 4mg QD |
| |||||||||||||
| Prezista 800mg/100mg QD |
| |||||||||||||
| NK-104 4mg QD & Prezista 800mg/100mg QD |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All randomized subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | NK-104 AUC | All subjects with measurable pharmacokinetic (PK) values. | Posted | Mean | Standard Deviation | ng * h/mL | 16 Days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All randomized subjects |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MEDRA v. 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Morgan, MD FACS | Kowa Research Institute, Inc | 919-433-1600 | RMorgan@kowaus.com |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
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| Darunavir/Ritonavir (Prezista) |
| Drug |
Darunavir/Ritonavir (Prezista) 800 mg/100 mg |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With at Least One Adverse Event. | All subjects who took at least one dose of study medication. | Posted | Number | Participants | 16 Days |
|
|
|
| 0 |
| 28 |
| 13 |
| 28 |
| Paresthesia | Nervous system disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Rash maculopapular | Skin and subcutaneous tissue disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MEDRA v. 14.0 | Non-systematic Assessment |
|
May not publish.
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |