Renal Insufficiency, Chronic
Conditions
Brief summary
The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
Interventions
DRUGPF-00734200
The drug is administered as a single dose of four 5-mg tablets
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis 2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg 3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications
Exclusion criteria
1. Women who are pregnant, nursing or women of childbearing potential 2. Subjects with acute renal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve from time 0 until last observation (AUCtlast) | 3-6 days |
| Maximum serum concentration (Cmax) | 3-6 days |
Secondary
| Measure | Time frame |
|---|---|
| Half life (T1/2) | 3-6 days |
| AUC extrapolated to infinity (AUCinf) | 3-6 days |
| Hemodialysis clearance (CLd) | 3 days |
| Renal clearance (CLr) | 3-6 days |
| Time of Cmax (Tmax) | 3-6 days |
Countries
United States
Outcome results
None listed