Overview
PF-04634817 Renal Impairment Study
Status:
Completed
Completed
Trial end date:
2013-09-01
2013-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Pfizer
Criteria
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