This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
50 mg IR suspension once daily for one day
50 mg shorter release CR once daily for one day
50 mg medium release CR once daily for one day
Pfizer Investigational Site
New Haven, Connecticut, United States
Various standard descriptive pharmacokinetics endpoints including: Cmin, Cmax, Tmax, AUC.
Time frame: 1 month
Safety laboratory testing including: blood electrolytes and liver and kidney function-related chemistries, complete blood counts, urinalysis, and electrocardiogram
Time frame: 1 month
Other safety parameters including: physical examination and vital signs.
Time frame: 1 month
Adverse Event Reporting as reported by subject and through investigator query and categorized by MedRA terminology.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
longer release SR formulation once daily for one day