The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
11
one 250mg tablet, once in the morning in fasted state
2x250 mg tablets, once in the morning, in fasted state
4x250mg tablets, once in the morning, in fasted state
Pfizer Investigational Site
New Haven, Connecticut, United States
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
Time frame: 48 hrs
safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing
Time frame: 48 hrs
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2x250mg tab, once in the morning, after being fed a high fat meal
4x125 mg tabs, once in the morning, in the fasted state. This arm will only occur as part of Part 2, if needed, pending results of Part 1.
4x125 mg IR once in the morning after being fed a high fat meal
2x250 mg controlled release formulation 5 tabs once in the morning in the fasted state
2x250 mg controlled release formulation 5 once in the morning after being fed a high fat meal