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.

Study Overview

• Status: Completed
• Conditions: Healthy; Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: PF-04991532

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pfizer Investigational Site
  • Florida
    • DeLand, Florida, United States, 32720
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUClast)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Maximum observed plasma concentration (Cmax)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Time of maximum observed plasma concentration (Tmax)	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Renal Clearance (Clr)	0 to 24 hours
Amount of drug excreted (Ae)	0 to 24 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 9, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 21, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Micronutrients; Vitamins; Vitamin B Complex; Nicotinic Acids; 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid
• Other Study ID Numbers: B2611011