Back to resultsA Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PF-03882845
PF-03882845
PF-03882845
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Relative bioavailability, food effect, tablet, suspension, single dose, crossover, healthy subjects
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Suspension/fasted
Tablet/fasted
Tablet/fed
Arm Description
Outcomes
Primary Outcome Measures
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
Post dose is measured at 24, 48 and 96 hours after dose.
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01366287
Brief Title
A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Relative bioavailability, food effect, tablet, suspension, single dose, crossover, healthy subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspension/fasted
Arm Type
Experimental
Arm Title
Tablet/fasted
Arm Type
Experimental
Arm Title
Tablet/fed
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-03882845
Intervention Description
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Intervention Type
Drug
Intervention Name(s)
PF-03882845
Intervention Description
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
Intervention Type
Drug
Intervention Name(s)
PF-03882845
Intervention Description
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition
Primary Outcome Measure Information:
Title
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
Description
Post dose is measured at 24, 48 and 96 hours after dose.
Time Frame
predose and post each dose (24, 48 and 96 hour timepoints)
Title
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171006&StudyName=A%20Study%20Of%20PF-03882845%20Absorption%20In%20Healthy%20Volunteers%20Given%20Orally%20As%20Tablet%20Versus%20Suspension%20Formulations%20And%20Effect%20Of%20Food%20On%20It
Description
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A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
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