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

NCT01043094 | Completed Phase 4 Results

• 1 other identifier: NK-104-4.01US
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))

  Area under the curve from start to elimination for Pitavastatin.

  48 hours

Secondary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  3 Days

Study Arms (2)

Pitavastatin 4mg renal impaired

EXPERIMENTAL

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

Drug: Pitavastatin 4mg

Pitavastatin 4mg healthy subjects

ACTIVE COMPARATOR

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

Drug: Pitavastatin 4mg

Interventions

Pitavastatin 4mg DRUG

Pitavastatin 4mg single dose

Pitavastatin 4mg healthy subjects; Pitavastatin 4mg renal impaired

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Unknown Facility

Minneapolis, Minnesota, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Roger Morgan, MD, FACS
• Organization: Kowa Research Institute, Inc.

RMorgan@KowaUS.com

919-433-1600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: January 6, 2010
• Study Start: December 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 13, 2012
• Results First Posted: August 13, 2012

Record last verified: 2012-07

Locations

US (1)