Conditions: Renal Insufficiency
Keywords: Subjects with Renal Impairment healthy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: PF-04634817 intervention 2: PF-04634817 intervention 3: PF-04634817 intervention 4: PF-04634817
Intervention descriptions: intervention 1: Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min) intervention 2: Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min) intervention 3: Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min) intervention 4: Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Protocol document: