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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01821079

Enrollment

Registered

2013-03-29

Start date

2013-03-31

Completion date

2013-04-30

Last updated

2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Single dose, Relative Bioavailability, Food effect, Healthy subjects, Diabetes Mellitus Type 2

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.

Interventions

DRUGPF-05175157

Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026