Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Completed · Phase 1
Conditions studied: Type 2 Diabetes Mellitus, Healthy
In brief
The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.
Key facts
- Study ID
- NCT01369602
- Run by
- Pfizer
- People needed
- 27
- Starts
- 2011-07-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2012-02-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Stable renal function defined as <20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. CrCl value at Screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
- Body Mass Index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lbs).
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
You may not qualify if…
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
- Subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (TIA).
- Subjects with severe heart failure (New York Heart Association Functional Class IV) at Screening.
- Subjects with acute renal disease.
Where it is running
- Pfizer Investigational Site — Anaheim, California, United States
- Pfizer Investigational Site — DeLand, Florida, United States
Full record on ClinicalTrials.gov
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