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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01369602
First received: June 7, 2011
Last updated: February 21, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Healthy
Drug: PF-04991532
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs ] [ Designated as safety issue: No ]
  • Renal Clearance (Clr) [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]
  • Amount of drug excreted (Ae) [ Time Frame: 0 to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy controls
healthy subjects (creatinine clearance > 90 mL/min)
Drug: PF-04991532
single dose 300-mg
Experimental: ESRD / severe renal insufficiency
Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace <15 mL/min OR requiring dialysis)
Drug: PF-04991532
single dose 300-mg
Experimental: Moderate renal impairment
Moderate (creatinine clearance = 30 to 59 mL/min)
Drug: PF-04991532
single dose 300-mg
Experimental: Mild renal impairment
Mild (creatinine clearance = 60 to 89 mL/min)
Drug: PF-04991532
single dose 300-mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369602

Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01369602     History of Changes
Other Study ID Numbers: B2611011
Study First Received: June 7, 2011
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014