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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: PF-05089771

• Registration Number: NCT01690351
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-10
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-05089771 TS formulation fasted	PF-05089771	Capsules TS formulation- fasted
PF-05089771 Oral Dispersion fasted	PF-05089771	Oral dispersion TS formulation- fasted

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium