PF-04634817 Renal Impairment Study

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NCT01791855

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Study Location
Pfizer Investigational Site
Deland, Florida, 32720, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE PF-04634817 Renal Impairment Study
Official Title  ICMJE A Phase 1, Single Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04634817
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Insufficiency
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Tesch GH, Pullen N, Jesson MI, Schlerman FJ, Nikolic-Paterson DJ. Combined inhibition of CCR2 and ACE provides added protection against progression of diabetic nephropathy in Nos3-deficient mice. Am J Physiol Renal Physiol. 2019 Dec 1;317(6):F1439-F1449. doi: 10.1152/ajprenal.00340.2019. Epub 2019 Sep 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2013)		26
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2013)		32
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01791855
Other Study ID Numbers  ICMJE B1261008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP