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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563497
• Other study ID #: B3291007
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2012
• Last updated: March 23, 2012
• Start date: February 2012
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Belgian Health Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• PF-05089771
Oral dispersion TS formulation- fasted
• PF-05089771
Tablets TS formulation- fasted
• PF-05089771
Tablets TS formulation- fed

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)		days 1-3	No
Primary	AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)		days 1-3	No
Primary	AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)		days 1-3	No
Primary	Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)		days 1-3	No
Primary	t½ = Elimination half life of PF-05089771 (hr)		days 1-3	No
Secondary	evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.		days 1-3	Yes

External Links

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