NCT01821079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

1 month

First QC Date

March 26, 2013

Last Update Submit

May 20, 2013

Conditions

Healthy

Keywords

Single doseRelative BioavailabilityFood effectHealthy subjectsDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (4)

PF-05175157 PIC in fed state

EXPERIMENTAL

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

Drug: PF-05175157

PF-05175157 tablet in fed state

EXPERIMENTAL

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

Drug: PF-05175157

PF-05175157 tablet in fed state (repeat)

EXPERIMENTAL

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

Drug: PF-05175157

PF-05175157 tablet in fasted state

EXPERIMENTAL

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

Interventions

PF-05175157DRUG

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

PF-05175157 PIC in fed state

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

March 29, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

US(1)