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

NCT01369602 | Completed Phase 1

• 1 other identifier: B2611011
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus; Healthy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

healthy controls

EXPERIMENTAL

healthy subjects (creatinine clearance \> 90 mL/min)

Drug: PF-04991532

ESRD / severe renal insufficiency

EXPERIMENTAL

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

Drug: PF-04991532

Moderate renal impairment

EXPERIMENTAL

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

Drug: PF-04991532

Mild renal impairment

EXPERIMENTAL

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

Drug: PF-04991532

Interventions

PF-04991532 DRUG

single dose 300-mg

healthy controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (2)