A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State

A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: PF-05089771; Drug: PF-05089771

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PF-05089771 Oral Dispersion fasted; Oral dispersion TS formulation- fasted	Drug: PF-05089771; Oral dispersion TS formulation- fasted; Drug: PF-05089771; Capsules TS formulation- fasted
EXPERIMENTAL: PF-05089771 TS formulation fasted; Capsules TS formulation- fasted	Drug: PF-05089771; Oral dispersion TS formulation- fasted; Drug: PF-05089771; Capsules TS formulation- fasted

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (ESTIMATE): September 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: B3291015