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

Renal Impairment Clinical Trial

Official title:

Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740362
• Other study ID #: A3921006
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2012
• Last updated: December 3, 2012
• Start date: October 2003
• Est. completion date: March 2004

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• CP-690,550
10 mg (2 x 5 mg tablets), single dose
• CP-690,550
10 mg (2 x 5 mg tablets), single dose
• CP-690,550
10 mg (2 x 5 mg tablets), single dose
• CP-690,550
10 mg (2 x 5 mg tablets), single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	AUC (0 - 8) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).	0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose	No
Primary	Maximum Observed Plasma Concentration (Cmax)		0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose	No
Primary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose	No
Primary	Renal Clearance (CL R)	Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.	0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose	No

External Links

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