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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

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: CP-945,598 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: Normal renal function Drug: CP-945,598
Administration of CP-945,598 in subjects with normal renal function.
Experimental: Severe renal impairment Drug: CP-945,598
Administration of CP-945,598 in subjects with severe renal impairment.



Primary Outcome Measures :
  1. 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 ]
  2. 28, 35 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 [ Time Frame: 14 days ]
  2. ECGs on Days 1,7 and 14 [ Time Frame: 14 days ]
  3. Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 [ Time Frame: 14 days ]
  4. Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472836


Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00472836     History of Changes
Other Study ID Numbers: A5351038
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: November 2008