A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05175157

Study type: Interventional

Funder types: Industry

Identifiers

NCT01821079

B1731014

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

PF-05175157 PIC in fed state

Experimental group

Description:

200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal).

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

PF-05175157 tablet in fed state

Experimental group

Description:

200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

PF-05175157 tablet in fed state (repeat)

Experimental group

Description:

200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

PF-05175157 tablet in fasted state

Experimental group

Description:

200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast).

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157