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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Pitavastatin (NK-104); Drug: Diltiazem (Cardizem LA) 240 mg QD

• Registration Number: NCT01422382
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2011-05
• Primary Completion: 2011-06
• Study Completion: 2011-07
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Results First Submitted: 2012-01-03
• Results First Submitted QC: 2012-04-11
• Results First Posted: 2012-04-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	Diltiazem (Cardizem LA) 240 mg QD	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
All Subjects	Pitavastatin (NK-104)	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

Primary Outcome Measures

Name	Time	Method
NK-104 AUC	15 Days

Secondary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Adverse Event.	24 Days