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PF-04634817 Renal Impairment Study
PF-04634817 Renal Impairment Study

NCT01791855

CompletedPhase 1

Sponsor: Pfizer

Conditions: Renal Insufficiency

Interventions: PF-04634817, PF-04634817, PF-04634817, PF-04634817

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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
Locations (2)
  • DeLand, Florida, United States
  • Miami, Florida, United States