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

Hyperlipidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634034
• Other study ID #: NK-104-CR-1.01US
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2015
• Last updated: January 8, 2016
• Start date: December 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• A: NK-104-CR 8 mg
NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
• B: Pitavastatin IR 4 mg
Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
• C: Pitavastatin IR 8 mg
Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve	Area Under the Curve 0 to tau	0 to 48 hours	No