search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04991532
PF-04991532
PF-04991532
PF-04991532
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

healthy controls

ESRD / severe renal insufficiency

Moderate renal impairment

Mild renal impairment

Arm Description

healthy subjects (creatinine clearance > 90 mL/min)

Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace <15 mL/min OR requiring dialysis)

Moderate (creatinine clearance = 30 to 59 mL/min)

Mild (creatinine clearance = 60 to 89 mL/min)

Outcomes

Primary Outcome Measures

Area under the plasma concentration versus time curve (AUClast)
Maximum observed plasma concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)
Renal Clearance (Clr)
Amount of drug excreted (Ae)

Secondary Outcome Measures

Full Information

First Posted
June 7, 2011
Last Updated
February 21, 2012
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01369602
Brief Title
Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Official Title
A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy controls
Arm Type
Experimental
Arm Description
healthy subjects (creatinine clearance > 90 mL/min)
Arm Title
ESRD / severe renal insufficiency
Arm Type
Experimental
Arm Description
Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace <15 mL/min OR requiring dialysis)
Arm Title
Moderate renal impairment
Arm Type
Experimental
Arm Description
Moderate (creatinine clearance = 30 to 59 mL/min)
Arm Title
Mild renal impairment
Arm Type
Experimental
Arm Description
Mild (creatinine clearance = 60 to 89 mL/min)
Intervention Type
Drug
Intervention Name(s)
PF-04991532
Intervention Description
single dose 300-mg
Intervention Type
Drug
Intervention Name(s)
PF-04991532
Intervention Description
single dose 300-mg
Intervention Type
Drug
Intervention Name(s)
PF-04991532
Intervention Description
single dose 300-mg
Intervention Type
Drug
Intervention Name(s)
PF-04991532
Intervention Description
single dose 300-mg
Primary Outcome Measure Information:
Title
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
Title
Maximum observed plasma concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Title
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
Title
Renal Clearance (Clr)
Time Frame
0 to 24 hours
Title
Amount of drug excreted (Ae)
Time Frame
0 to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611011&StudyName=Study%20To%20Evaluate%20The%20Effect%20Of%20Renal%20Impairment%20On%20The%20Pharmacokinetics%20Of%20PF-04991532
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs