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NCT01366287 Clinical Trial

A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01366287
Other study ID # B0171006
Secondary ID
Status Completed
Phase Phase 1
First received January 4, 2011
Last updated June 2, 2011
Start date January 2011
Est. completion date February 2011

Study information
Verified date June 2011
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 estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.

- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

- Serum potassium >5 mEq/L at screening.

- Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• PF-03882845
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
• PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
• PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition

Locations
Country Name City State
Belgium Pfizer Investigational Site Bruxelles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit. Post dose is measured at 24, 48 and 96 hours after dose. predose and post each dose (24, 48 and 96 hour timepoints) No
Primary Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring. 45 days Yes
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