Clinical trial NCT01563497: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
timeFrame: days 1-3
measure: AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)
timeFrame: days 1-3
measure: AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
timeFrame: days 1-3
measure: Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
timeFrame: days 1-3
measure: t½ = Elimination half life of PF-05089771 (hr)
timeFrame: days 1-3
Secondary outcomes:
measure: evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.
timeFrame: days 1-3
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: