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

NCT02634034 | Completed Phase 1

• 1 other identifier: NK-104-CR-1.01US
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve

  Area Under the Curve 0 to tau

  0 to 48 hours

Study Arms (3)

NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)

EXPERIMENTAL

Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg

Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)

EXPERIMENTAL

Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg

Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)

EXPERIMENTAL

Drug: A: NK-104-CR 8 mg; Drug: B: Pitavastatin IR 4 mg; Drug: C: Pitavastatin IR 8 mg

Interventions

A: NK-104-CR 8 mg DRUG

NK-104-CR 8 mg (Controlled Release single 8-mg tablet)

NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg); Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg); Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)

B: Pitavastatin IR 4 mg DRUG

Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)

NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg); Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg); Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)

C: Pitavastatin IR 8 mg DRUG

Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)

NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg); Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg); Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)