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Trial record 1 of 1 for:    NCT01821079
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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

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ClinicalTrials.gov Identifier: NCT01821079
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 26, 2013
First Posted Date  ICMJE March 29, 2013
Last Update Posted Date May 21, 2013
Study Start Date  ICMJE March 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 to 72 H after dose ]
  • Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) [ Time Frame: 0 to 72 H after dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 to 72 H after dose ]
  • Time at which maximum plasma concentration is observed (Tmax) [ Time Frame: 0 to 72 H after dose ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0 to 72 H after dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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).
    Intervention: Drug: PF-05175157
  • 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).
    Intervention: Drug: PF-05175157
  • 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).
    Intervention: Drug: PF-05175157
  • 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).
    Intervention: Drug: PF-05175157
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2013)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821079
Other Study ID Numbers  ICMJE B1731014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP