Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin
Study Details
Study Description
Brief Summary
This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: All Subjects There was 1 treatment period, with each subject receiving 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 |
Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Names:
Drug: Diltiazem (Cardizem LA) 240 mg QD
Diltiazem (Cardizem LA) 240 mg QD
|
Outcome Measures
Primary Outcome Measures
- NK-104 AUC [15 Days]
Secondary Outcome Measures
- Number of Participants With at Least One Adverse Event. [24 Days]
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-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.
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-104-4.07US
Study Results
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 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | All randomized subjects. |
| Period Title: NK-104 4mg Once Daily (QD) | |
| STARTED | 28 |
| COMPLETED | 28 |
| NOT COMPLETED | 0 |
| Period Title: NK-104 4mg Once Daily (QD) | |
| STARTED | 28 |
| COMPLETED | 28 |
| NOT COMPLETED | 0 |
| Period Title: NK-104 4mg Once Daily (QD) | |
| STARTED | 28 |
| COMPLETED | 27 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | All randomized subjects. |
| Overall Participants | 28 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
28
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
29.2
(7.63)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
11
39.3%
|
| Male |
17
60.7%
|
| Region of Enrollment (participants) [Number] | |
| United States |
28
100%
|
Outcome Measures
| Title | NK-104 AUC |
|---|---|
| Description | |
| Time Frame | 15 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects with measurable pharmacokinetic (PK) values |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | All randomized subjects. |
| Measure Participants | 26 |
| Mean (Standard Deviation) [ng * h/mL] |
208.92
(86.54)
|
| Title | Number of Participants With at Least One Adverse Event. |
|---|---|
| Description | |
| Time Frame | 24 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Subjects |
|---|---|
| Arm/Group Description | All randomized subjects. |
| Measure Participants | 28 |
| Number [Participants] |
12
42.9%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Subjects | |
| Arm/Group Description | All randomized subjects. | |
All Cause Mortality |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/28 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/28 (42.9%) | |
| Infections and infestations | ||
| Nasopharyngitis | 2/28 (7.1%) | |
| Nervous system disorders | ||
| Headache | 5/28 (17.9%) | |
| Presyncope | 3/28 (10.7%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 2/28 (7.1%) | |
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-104-4.07US