Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740362

A3921006

Details and patient eligibility

About

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
• Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Exclusion criteria

• Kidney transplant patients
• Subjects with any condition possibly affecting drug absorption
• Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Healthy volunteers

Other group

Description:

Healthy volunteers

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Mild renal impairment

Experimental group

Description:

patients with mild (\>50 and ≤80 mL/min) renal impairment

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Moderate renal impairment

Experimental group

Description:

patients with moderate (≥30 and ≤50 mL/min) renal impairment

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

severe renal impairment

Experimental group

Description:

patients with severe (\<30 mL/min) renal impairment

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550

Drug: CP-690,550