Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers

NCT ID: NCT01043094

Last Updated: 2012-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-12-31

Brief Summary

This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B):

The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.

Conditions

Severe Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Pitavastatin 4mg renal impaired

Subjects with severe renal impairment (glomerular filtration rate \[GFR\] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis

Group Type: EXPERIMENTAL

Pitavastatin 4mg

Intervention Type: DRUG

Pitavastatin 4mg single dose

Pitavastatin 4mg healthy subjects

Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)

Group Type: ACTIVE_COMPARATOR

Pitavastatin 4mg

Intervention Type: DRUG

Pitavastatin 4mg single dose

Interventions

Pitavastatin 4mg

Pitavastatin 4mg single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.
• Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis [if able to pass urine]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.
• Subject provides written informed consent before any study-specific evaluation is performed.
• Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria

• Subject is on maintenance hemodialysis.
• Subject has a BMI of >37 kg/m2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

NK-104-4.01US

Identifier Type: -

Identifier Source: org_study_id