NCT01366287CompletedPhase 1
A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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/m
- •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.
Arms & Interventions
Suspension/fasted
Experimental
Intervention: PF-03882845 (Drug)
Tablet/fasted
Experimental
Intervention: PF-03882845 (Drug)
Tablet/fed
Experimental
Intervention: PF-03882845 (Drug)
Outcomes
Primary Outcomes
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.
Time Frame: predose and post each dose (24, 48 and 96 hour timepoints)
Post dose is measured at 24, 48 and 96 hours after dose.
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
Time Frame: 45 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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