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

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ClinicalTrials.gov Identifier: NCT00472836
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : August 13, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 11, 2007
First Posted Date  ICMJE May 14, 2007
Last Update Posted Date August 13, 2009
Study Start Date  ICMJE June 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2008)
  • Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21, [ Time Frame: 14 days ]
  • 28, 35 [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2007)
Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, 35
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 [ Time Frame: 14 days ]
  • ECGs on Days 1,7 and 14 [ Time Frame: 14 days ]
  • Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 [ Time Frame: 14 days ]
  • Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2007)
Vital signs (Blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 ECGs on Days 1,7 and 14 Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 Adverse event monitoring throughout duration of the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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