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Trial record 1 of 1 for:    NCT01563497
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A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563497
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 23, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date March 27, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
  • Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: days 1-3 ]
  • AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) [ Time Frame: days 1-3 ]
  • AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: days 1-3 ]
  • Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: days 1-3 ]
  • t½ = Elimination half life of PF-05089771 (hr) [ Time Frame: days 1-3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: days 1-3 ]
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 Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State
Official Title  ICMJE A Phase 1, Open-Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Tablet To PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And The Fed State
Brief Summary The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.
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: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: PF-05089771
    Oral dispersion TS formulation- fasted
  • Drug: PF-05089771
    Tablets TS formulation- fasted
  • Drug: PF-05089771
    Tablets TS formulation- fed
Study Arms  ICMJE
  • Experimental: PF-05089771 Oral Dispersion fasted
    Oral dispersion TS formulation- fasted
    Intervention: Drug: PF-05089771
  • Experimental: PF-05089771 TS formulation fasted
    Tablets TS formulation- fasted
    Intervention: Drug: PF-05089771
  • Experimental: PF-05089771 TS formulation fed
    Tablets TS formulation- fed
    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: March 23, 2012)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal,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).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds >120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
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 NCT01563497
Other Study ID Numbers  ICMJE B3291007
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 March 2012

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