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

Phase 4

Completed

• Conditions: Severe Renal Impairment
• Interventions: Drug: Pitavastatin 4mg

• Registration Number: NCT01043094
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-06
• Primary Completion: 2010-04
• Study Completion: 2010-12
• Results First Submitted: 2012-03-23
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-05
• Last Update Submitted: 2012-07-05
• Results First Posted: 2012-08-13
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4mg healthy subjects	Pitavastatin 4mg	Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
Pitavastatin 4mg renal impaired	Pitavastatin 4mg	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

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))	48 hours	Area under the curve from start to elimination for Pitavastatin.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	3 Days