NCT01563497CompletedPhase 1
A Phase 1, Open-Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Tablet To PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And The Fed State
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
Study Overview
Brief Summary
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- •Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest
- •Single 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds >120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
Arms & Interventions
PF-05089771 Oral Dispersion fasted
Experimental
Oral dispersion TS formulation- fasted
Intervention: PF-05089771 (Drug)
PF-05089771 TS formulation fasted
Experimental
Tablets TS formulation- fasted
Intervention: PF-05089771 (Drug)
PF-05089771 TS formulation fed
Experimental
Tablets TS formulation- fed
Intervention: PF-05089771 (Drug)
Outcomes
Primary Outcomes
Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
Time Frame: days 1-3
AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)
Time Frame: days 1-3
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
Time Frame: days 1-3
Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
Time Frame: days 1-3
t½ = Elimination half life of PF-05089771 (hr)
Time Frame: days 1-3
Secondary Outcomes
- evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.(days 1-3)
Investigators
Study Sites (1)
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