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

Last updated on October 5, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Type 2 Diabetes Mellitus
  • Healthy
Drug: PF-04991532
single dose 300-mg
  • Experimental: healthy controls
    healthy subjects (creatinine clearance > 90 mL/min)
    Intervention: Drug: PF-04991532
  • Experimental: ESRD / severe renal insufficiency
    Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace <15 mL/min OR requiring dialysis)
    Intervention: Drug: PF-04991532
  • Experimental: Moderate renal impairment
    Moderate (creatinine clearance = 30 to 59 mL/min)
    Intervention: Drug: PF-04991532
  • Experimental: Mild renal impairment
    Mild (creatinine clearance = 60 to 89 mL/min)
    Intervention: Drug: PF-04991532
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01369602
B2611011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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