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

Healthy Clinical Trial

Official title:

A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369602
• Other study ID #: B2611011
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2011
• Last updated: February 21, 2012
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Healthy
• Renal Insufficiency
• Type 2 Diabetes Mellitus

Intervention

Drug:
• PF-04991532
single dose 300-mg
• PF-04991532
single dose 300-mg
• PF-04991532
single dose 300-mg
• PF-04991532
single dose 300-mg

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	DeLand	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Maximum observed plasma concentration (Cmax)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs	No
Primary	Time of maximum observed plasma concentration (Tmax)		0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs	No
Primary	Renal Clearance (Clr)		0 to 24 hours	No
Primary	Amount of drug excreted (Ae)		0 to 24 hours	No

External Links

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