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Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus, Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Stable renal function defined as 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01369602
Pfizer
Completed
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532

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[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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