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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

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ClinicalTrials.gov Identifier: NCT01563497
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Pain Drug: PF-05089771 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2012
Primary Completion Date : February 2012
Study Completion Date : February 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: days 1-3 ]
  2. AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) [ Time Frame: days 1-3 ]
  3. AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: days 1-3 ]
  4. Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: days 1-3 ]
  5. t½ = Elimination half life of PF-05089771 (hr) [ Time Frame: days 1-3 ]

Secondary Outcome Measures :
  1. evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: days 1-3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01563497     History of Changes
Other Study ID Numbers: B3291007
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012