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Completed

NCT Number: NCT01740362

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-690,550

Drug

10 mg (2 x 5 mg tablets), single dose

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

  4. Plasma Decay Half-Life (t1/2)

    Time frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  5. Renal Clearance (CL R)

    Time frame: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose

    Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 4, 2012
Registry last updated
Jan 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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