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Trial record 1 of 1 for:    NCT01854996
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Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

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ClinicalTrials.gov Identifier: NCT01854996
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 8, 2013
First Posted Date  ICMJE May 16, 2013
Last Update Posted Date June 25, 2013
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 48 hours ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: 48 hours ]
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 Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion
Official Title  ICMJE A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers
Brief Summary This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).
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-05089771
450mg
Other Name: no specified
Study Arms  ICMJE
  • Experimental: Oral disperion fasted
    A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions.
    Intervention: Drug: PF-05089771
  • Experimental: Capsule fasted
    single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions
    Intervention: Drug: PF-05089771
  • Experimental: Capsule fed
    single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions
    Intervention: Drug: PF-05089771
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: May 13, 2013)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 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 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy)
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01854996
Other Study ID Numbers  ICMJE B3291020
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 June 2013

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