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
  Purpose

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


Condition Intervention Phase
Pain
Drug: PF-05089771
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: February 2012
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05089771 Oral Dispersion fasted
Oral dispersion TS formulation- fasted
Drug: PF-05089771
Oral dispersion TS formulation- fasted
Experimental: PF-05089771 TS formulation fasted
Tablets TS formulation- fasted
Drug: PF-05089771
Tablets TS formulation- fasted
Experimental: PF-05089771 TS formulation fed
Tablets TS formulation- fed
Drug: PF-05089771
Tablets TS formulation- fed

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563497

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01563497     History of Changes
Other Study ID Numbers: B3291007
Study First Received: March 23, 2012
Last Updated: March 23, 2012
Health Authority: Belgium: Belgian Health Authority

ClinicalTrials.gov processed this record on August 01, 2014