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Completed

NCT Number: NCT01821079

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-05175157

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 to 72 H after dose

  2. Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)

    Time frame: 0 to 72 H after dose

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0 to 72 H after dose

  2. Time at which maximum plasma concentration is observed (Tmax)

    Time frame: 0 to 72 H after dose

  3. Plasma Decay Half-Life (t1/2)

    Time frame: 0 to 72 H after dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2013
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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