A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers

The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject provides written informed consent before any study-specific evaluation is performed.
• Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
• Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.
• Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

• Subject is a woman who is pregnant or breastfeeding.
• Subject has clinically relevant abnormalities in the screening or check-in assessments.
• Subject has received an investigational drug within 30 days before the first dose of study drug.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)	Drug: A: NK-104-CR 8 mg; NK-104-CR 8 mg (Controlled Release single 8-mg tablet); Drug: B: Pitavastatin IR 4 mg; Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet); Drug: C: Pitavastatin IR 8 mg; Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Experimental: Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)	Drug: A: NK-104-CR 8 mg; NK-104-CR 8 mg (Controlled Release single 8-mg tablet); Drug: B: Pitavastatin IR 4 mg; Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet); Drug: C: Pitavastatin IR 8 mg; Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
Experimental: Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)	Drug: A: NK-104-CR 8 mg; NK-104-CR 8 mg (Controlled Release single 8-mg tablet); Drug: B: Pitavastatin IR 4 mg; Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet); Drug: C: Pitavastatin IR 8 mg; Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve	Area Under the Curve 0 to tau	0 to 48 hours

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pitavastatin
• Other Study ID Numbers: NK-104-CR-1.01US