PF-04634817 Renal Impairment Study
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/19/2013 |
| Start Date: | May 2013 |
| End Date: | September 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Single Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04634817
Patients with renal impairment are the target population for PF-04634817. The clearance
mechanism of this drug means that exposure may be increased in subjects with renal
impairment. This study will investigate the effect of the drug in subjects with varying
degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.
Inclusion Criteria:
- Male or female (non child bearing potential aged 18-75 years
- Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation)
or matched healthy volunteers (age, weight and gender)
Exclusion Criteria:
- Subjects with acute renal failure
- Subjects receiving, or likely to receive, CYP450 3A4 inhibitors
- Abnormal ECG at screening
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