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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01422382
First received: August 22, 2011
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Pitavastatin (NK-104)
Drug: Diltiazem (Cardizem LA) 240 mg QD
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • NK-104 AUC [ Time Frame: 15 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With at Least One Adverse Event. [ Time Frame: 24 Days ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Livalo
Drug: Diltiazem (Cardizem LA) 240 mg QD
Diltiazem (Cardizem LA) 240 mg QD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422382

Locations
United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
Study Director: Roger Morgan, MD, FACS Kowa Research Institute, Inc.
  More Information

No publications provided

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01422382     History of Changes
Other Study ID Numbers: NK-104-4.07US
Study First Received: August 22, 2011
Results First Received: January 3, 2012
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers

Additional relevant MeSH terms:
Diltiazem
Pitavastatin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 16, 2014