You are here

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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33169 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Renal Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-77 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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

2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight
greater than 50 kg

3. Subjects in the normal renal function category must be healthy and not receiving any
chronic treatment with prescription or non-prescription medications

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Women who are pregnant, nursing or women of childbearing potential

2. Subjects with acute renal disease.

NCT00596518
Pfizer
Completed
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Chronic Disease, Pain
NCT01179191
All Genders
21+
Years
Multiple Sites
Chronic Pain, Hip Osteoarthritis, Knee Osteoarthritis
NCT02528188
All Genders
18+
Years
Multiple Sites
Renal Cell Carcinoma
NCT00043407
All Genders
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Renal Insufficiency, Chronic
Drug: PF-00734200
The drug is administered as a single dose of four 5-mg tablets
Experimental: PF-00734200
Intervention: Drug: PF-00734200
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
  3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications

Exclusion Criteria:

  1. Women who are pregnant, nursing or women of childbearing potential
  2. Subjects with acute renal disease.
Sexes Eligible for Study: All
18 Years to 77 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00596518
A7941014
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now