PF-04634817 Renal Impairment Study

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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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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