Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin

Study Overview
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Brief Summary
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This is a Phase 4, single-center, open-label, fixed-sequence, multiple-dose, 2-way drug-drug interaction study.

Detailed Description
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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.

Official Title
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Drug-Drug Interaction Study to Assess the Effects of Steady-State Cardizem LA (Diltiazem Hydrochloride) and Steady-State Pitavastatin on Their Respective Pharmacokinetics in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pitavastatin (NK-104)
* Drug: Diltiazem (Cardizem LA) 240 mg QD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Subjects<br>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)<br>* pitavastatin (NK-104) 4 mg once daily (QD)<br>* Other names: Livalo;Drug: Diltiazem (Cardizem LA) 240 mg QD<br>* Diltiazem (Cardizem LA) 240 mg QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK-104 AUC |  | 15 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Adverse Event. |  | 24 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers