A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted 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. Identifier: NCT01690351
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : December 12, 2012
Information provided by (Responsible Party):

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

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

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 Oral Dispersion To PF-05089771 TS Capsule
Study Start Date : September 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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
Capsules TS formulation- fasted
Drug: PF-05089771
Capsules TS formulation- fasted

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

Secondary Outcome Measures :
  1. evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: days 1-2 ]

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

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.

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 identifier (NCT number): NCT01690351

Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01690351     History of Changes
Other Study ID Numbers: B3291015
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012