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

NCT01422382 | Completed Phase 4 Results

• 1 other identifier: NK-104-4.07US
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• NK-104 AUC

  15 Days

Secondary Outcomes (1)

• Number of Participants With at Least One Adverse Event.

  24 Days

Study Arms (1)

All Subjects

EXPERIMENTAL

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); Drug: Diltiazem (Cardizem LA) 240 mg QD

Interventions

Pitavastatin (NK-104) DRUG

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

Also known as: Livalo

All Subjects

Diltiazem (Cardizem LA) 240 mg QD DRUG

Diltiazem (Cardizem LA) 240 mg QD

All Subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Interventions

pitavastatin; Diltiazem

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Roger Morgan, MD FACS
• Organization: Kowa Research Institute, Inc

RMorgan@kowaus.com

919-433-1600

Study Officials

• Roger Morgan, MD, FACS

  Kowa Research Institute, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 24, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 13, 2012
• Results First Posted: April 12, 2012

Record last verified: 2012-07

Locations

US (1)