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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01563497
First received: March 23, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 23, 2012
March 23, 2012
February 2012
February 2012   (final data collection date for primary outcome measure)
  • Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: days 1-3 ] [ Designated as safety issue: No ]
  • AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) [ Time Frame: days 1-3 ] [ Designated as safety issue: No ]
  • AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: days 1-3 ] [ Designated as safety issue: No ]
  • Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: days 1-3 ] [ Designated as safety issue: No ]
  • t½ = Elimination half life of PF-05089771 (hr) [ Time Frame: days 1-3 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: days 1-3 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Drug: PF-05089771
    Oral dispersion TS formulation- fasted
  • Drug: PF-05089771
    Tablets TS formulation- fasted
  • Drug: PF-05089771
    Tablets TS formulation- fed
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01563497
B3291007
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

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