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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-05175157; Drug: PF-05175157

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg); Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
Experimental: 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).	Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg); Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
Experimental: 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).	Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg); Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
Experimental: 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).	Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg); Drug: PF-05175157; Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 21, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Food effect; Healthy subjects; Diabetes Mellitus Type 2; Relative Bioavailability; Single dose
• Other Study ID Numbers: B1731014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No