Phase 4
N=16
Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
Severe Renal Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01043094 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) — 175; 145 nanogram hour per milliliter (ng•h/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pitavastatin 4mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Institute, Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) |
175; 145 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
3; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01043094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.