At a glance
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A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS OF PF-04634817
In Brief
A Phase 1 clinical trial evaluating PF-04634817 for Renal Insufficiency. Completed, enrolled 32 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)