Pain
Conditions
Brief summary
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.
Interventions
DRUGPF-05089771
Oral dispersion TS formulation- fasted
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. | days 1-2 |
Countries
Belgium
Outcome results
None listed