Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

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NCT00472836

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Normal Subjects: 1.Healthy. 2.Matched for age (± 5 yrs), weight (± 10 kg), and gender ratio (± 2 subjects per gender).

- Subjects with Renal Disease: 1. Severe impairment (Creatinine clearance <30 mL/min) 2. Stable renal disease:no change in the last 30 days. 3. Stable dose of medication and/or treatment. 4. Reasonably well-controlled type 1 and type 2 diabetics

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


- All subjects: Non-prescribed use of drugs of abuse/ recreational drugs; recent
treatment with experimental drugs or herbal experiments; EKG and blood pressure
parameters falling outside of protocol-specified limits; history of regular alcohol or
tobacco use exceeding protocol-specified limits


- Normal subjects: Medically important health conditions; recent use of prescription or
non-prescription medications.


- Subjects with renal disease: Subjects requiring dialysis; certain chronic medical
conditions; patients who have received renal transplant; severe and/or poorly
controlled diabetes; Treatment with protocol-specified drugs that may alter the way
the body absorbs or processes CP-945,598.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Official Title  ICMJE A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Severely Impaired And Normal Renal Function
Brief Summary CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control subjects.
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: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with normal renal function.
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with severe renal impairment.
Study Arms  ICMJE
  • Experimental: Normal renal function
    Intervention: Drug: CP-945,598
  • Experimental: Severe renal impairment
    Intervention: Drug: CP-945,598
Publications * Not Provided

*   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: April 23, 2009)		17
Original Enrollment  ICMJE
 (submitted: May 11, 2007)		16
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal Subjects: 1.Healthy. 2.Matched for age (± 5 yrs), weight (± 10 kg), and gender ratio (± 2 subjects per gender).
  • Subjects with Renal Disease: 1. Severe impairment (Creatinine clearance <30 mL/min) 2. Stable renal disease:no change in the last 30 days. 3. Stable dose of medication and/or treatment. 4. Reasonably well-controlled type 1 and type 2 diabetics

Exclusion Criteria:

  • All subjects: Non-prescribed use of drugs of abuse/ recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure parameters falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits
  • Normal subjects: Medically important health conditions; recent use of prescription or non-prescription medications.
  • Subjects with renal disease: Subjects requiring dialysis; certain chronic medical conditions; patients who have received renal transplant; severe and/or poorly controlled diabetes; Treatment with protocol-specified drugs that may alter the way the body absorbs or processes CP-945,598.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 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 NCT00472836
Other Study ID Numbers  ICMJE A5351038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2008

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