A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation Of Pf-05175157 And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation In Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax)
Study Overview
Brief Summary
The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.
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, inclusive
- •Women must be of non childbearing potential
- •Body Mass Index (BMI) of 25 to 35 kg/m2; and a total body weight >50 kg (110 lbs)
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
- •History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0
Arms & Interventions
PF-05175157 PIC in fed state
200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal).
Intervention: PF-05175157 (Drug)
PF-05175157 tablet in fed state
200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).
Intervention: PF-05175157 (Drug)
PF-05175157 tablet in fed state (repeat)
200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).
Intervention: PF-05175157 (Drug)
PF-05175157 tablet in fasted state
200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast).
Intervention: PF-05175157 (Drug)
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0 to 72 H after dose
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Time Frame: 0 to 72 H after dose
Secondary Outcomes
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 to 72 H after dose)
- Time at which maximum plasma concentration is observed (Tmax)(0 to 72 H after dose)
- Plasma Decay Half-Life (t1/2)(0 to 72 H after dose)