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PF-04634817 Renal Impairment Study

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Deland, Florida, 32720 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Subjects with acute renal failure

- Subjects receiving, or likely to receive, CYP450 3A4 inhibitors

- Abnormal ECG at screening

NCT01791855
Pfizer
Completed
PF-04634817 Renal Impairment Study

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PF-04634817 Renal Impairment Study
A Phase 1, Single Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04634817
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Renal Insufficiency
  • Drug: PF-04634817
    Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
  • Drug: PF-04634817
    Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
  • Drug: PF-04634817
    Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
  • Drug: PF-04634817
    Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)
  • Experimental: Healthy Volunteers
    Intervention: Drug: PF-04634817
  • Experimental: Mild Renal Impairment
    Intervention: Drug: PF-04634817
  • Experimental: Moderate renal impairment
    Intervention: Drug: PF-04634817
  • Experimental: Severe renal impairment
    Intervention: Drug: PF-04634817
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
September 2013
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01791855
B1261008
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2013

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.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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