Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Completed · Phase 1
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00472836
- Run by
- Pfizer
- People needed
- 17
- Starts
- 2007-06-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2009-08-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Anaheim, California, United States
- Pfizer Investigational Site — Miami, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.