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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Pain

Treatments

Drug: PF-05089771

Study type

Interventional

Funder types

Industry

Identifiers

B3291015

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.