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

NCT ID: NCT01422382

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-07-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pitavastatin (NK-104)

Intervention Type: DRUG

pitavastatin (NK-104) 4 mg once daily (QD)

Diltiazem (Cardizem LA) 240 mg QD

Intervention Type: DRUG

Diltiazem (Cardizem LA) 240 mg QD

Interventions

Pitavastatin (NK-104)

pitavastatin (NK-104) 4 mg once daily (QD)

Intervention Type: DRUG

Diltiazem (Cardizem LA) 240 mg QD

Diltiazem (Cardizem LA) 240 mg QD

Intervention Type: DRUG

Other Intervention Names

Livalo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Morgan, MD, FACS

Role: STUDY_DIRECTOR

Kowa Research Institute, Inc.

Locations

Austin, Texas, United States

Countries

United States

Other Identifiers

NK-104-4.07US

Identifier Type: -

Identifier Source: org_study_id