Severe Renal Impairment
Conditions
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.
Interventions
DRUGPitavastatin 4mg
Pitavastatin 4mg single dose
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 3 Days |
Countries
United States
Participant flow
Recruitment details
Study period was from 23 November 2009 to 07 June 2010 All subjects were seen at a medical clinic
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Pitavastatin 4mg Healthy Subjects Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2) | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Pitavastatin 4mg Healthy Subjects | Pitavastatin 4mg Renal Impaired | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 14 Participants |
| Age Continuous | 52.0 years STANDARD_DEVIATION 2.62 | 54.1 years STANDARD_DEVIATION 15.41 | 53.1 years STANDARD_DEVIATION 10.74 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))
Area under the curve from start to elimination for Pitavastatin.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4mg Renal Impaired | Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) | 175 nanogram hour per milliliter (ng•h/mL) | Standard Deviation 39 |
| Pitavastatin 4mg Healthy Subjects | Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL)) | 145 nanogram hour per milliliter (ng•h/mL) | Standard Deviation 55 |
Secondary
Number of Participants With Treatment Emergent Adverse Events
Time frame: 3 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pitavastatin 4mg Renal Impaired | Number of Participants With Treatment Emergent Adverse Events | 3 Participants |
| Pitavastatin 4mg Healthy Subjects | Number of Participants With Treatment Emergent Adverse Events | 3 Participants |