Status:
COMPLETED
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Lead Sponsor:
Pfizer
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00472836
Start Date
June 1 2007
End Date
October 1 2008
Last Update
August 13 2009
Active Locations (2)
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1
Pfizer Investigational Site
Anaheim, California, United States, 92801
2
Pfizer Investigational Site
Miami, Florida, United States, 33169