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Completed

NCT Number: NCT00596518

A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Miami, 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 must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
  • Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
  • Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications

Exclusion criteria

  • Women who are pregnant, nursing or women of childbearing potential
  • Subjects with acute renal disease.

Treatment and study plan

PF-00734200

Drug

The drug is administered as a single dose of four 5-mg tablets

Primary outcomes

  1. Area under the curve from time 0 until last observation (AUCtlast)

    Time frame: 3-6 days

  2. Maximum serum concentration (Cmax)

    Time frame: 3-6 days

Secondary outcomes

  1. AUC extrapolated to infinity (AUCinf)

    Time frame: 3-6 days

  2. Time of Cmax (Tmax)

    Time frame: 3-6 days

  3. Half life (T1/2)

    Time frame: 3-6 days

  4. Renal clearance (CLr)

    Time frame: 3-6 days

  5. Hemodialysis clearance (CLd)

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 17, 2008
Registry last updated
Mar 10, 2017

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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