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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy; Type 2 Diabetes Mellitus

Treatments: Drug: PF-04991532

Study type: Interventional

Funder types: Industry

Identifiers

NCT01369602

B2611011

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

healthy controls

Experimental group

Description:

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

Treatment:

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

ESRD / severe renal insufficiency

Experimental group

Description:

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

Treatment:

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Moderate renal impairment

Experimental group

Description:

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

Treatment:

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Mild renal impairment

Experimental group

Description:

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

Treatment:

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532

Drug: PF-04991532