A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
Overview
- Phase
- Phase 1
- Intervention
- PF-04991532
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Pfizer
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUClast)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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.
Arms & Interventions
healthy controls
healthy subjects (creatinine clearance \> 90 mL/min)
Intervention: PF-04991532
ESRD / severe renal insufficiency
Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace \<15 mL/min OR requiring dialysis)
Intervention: PF-04991532
Moderate renal impairment
Moderate (creatinine clearance = 30 to 59 mL/min)
Intervention: PF-04991532
Mild renal impairment
Mild (creatinine clearance = 60 to 89 mL/min)
Intervention: PF-04991532
Outcomes
Primary Outcomes
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
Maximum observed plasma concentration (Cmax)
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
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
Renal Clearance (Clr)
Time Frame: 0 to 24 hours
Amount of drug excreted (Ae)
Time Frame: 0 to 24 hours