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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05175157

• Registration Number: NCT01821079
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-05175157 tablet in fed state (repeat)	PF-05175157	200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).
PF-05175157 tablet in fasted state	PF-05175157	200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast).
PF-05175157 PIC in fed state	PF-05175157	200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal).
PF-05175157 tablet in fed state	PF-05175157	200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	0 to 72 H after dose
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)	0 to 72 H after dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States