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Completed

NCT Number: NCT01791855

PF-04634817 Renal Impairment Study

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Avail Clinical Research, LLC, DeLand, 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

  • 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

Treatment and study plan

PF-04634817

Drug

Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)

Primary outcomes

  1. Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)]

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

    AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

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

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

  4. Apparent Oral Clearance (CL/F)

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  5. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

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

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

  7. Apparent Volume of Distribution (Vz/F)

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

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

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose

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

Secondary outcomes

  1. Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48)

    Time frame: 0-24, 24-48 hours post dose

    Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine.

  2. Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%)

    Time frame: 0-24, 24-48 post dose

    Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100).

  3. Renal Clearance Over a 48-hour Interval(CLr48)

    Time frame: 0-24, 24-48 hours post dose

    Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, SINGLE DOSE, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF RENAL IMPAIRMENT ON THE PHARMACOKINETICS OF PF-04634817

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2013
Registry last updated
Mar 1, 2024

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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