NCT01791855

PF-04634817 Renal Impairment Study

A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS OF PF-04634817

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	PF-04634817	Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
DRUG	PF-04634817	Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
DRUG	PF-04634817	Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
DRUG	PF-04634817	Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Timeline

• Start date: 2013-05-10
• Primary completion: 2013-09-03
• Completion: 2013-09-03
• First posted: 2013-02-15
• Last updated: 2024-03-01
• Results posted: 2024-03-01

Locations

2 sites across 1 country: United States