Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | June 2015 |
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Substitution, Crossover, Single Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf 06650833 Delivered In Multiple Formulations In Healthy Subjects Under Fasted And Fed Conditions
This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals
are to assess the safety, tolerability and blood levels of ascending doses of multiple
formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on
exposure, in healthy subjects.
are to assess the safety, tolerability and blood levels of ascending doses of multiple
formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on
exposure, in healthy subjects.
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential between the ages of
18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lbs).
Exclusion Criteria:
- Screening supine blood pressure 100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140
mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest.
If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should
be repeated two more times and the average of the three BP values should be used to
determine the subject's eligibility.
- Pulse or heart rate (HR) >100 bpm after at least 5 minutes of rest. If the pulse/HR
is >100 bpm, the pulse/HR should be repeated two more times (separated by at least 2
minutes) and the average of the three pulse/HR values should be used to determine the
subject's eligibility.
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