PF-04634817 Renal Impairment Study

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: PF-04634817

Study type: Interventional

Funder types: Industry

Identifiers

NCT01791855

2013-000360-29 (EudraCT Number)

B1261008

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Healthy Volunteers

Experimental group

Treatment:

Drug: PF-04634817

Mild Renal Impairment

Experimental group

Treatment:

Drug: PF-04634817

Moderate renal impairment

Experimental group

Treatment:

Drug: PF-04634817

Severe renal impairment

Experimental group

Treatment:

Drug: PF-04634817