The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
CE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal.
CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
Pfizer Investigational Site
Anniston, Alabama, United States
Pfizer Investigational Site
Anniston, Alabama, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Safety and tolerability assessed via AEs/SAEs, plus where applicable gastrointestinal symptoms checklist, clinical laboratory tests, vital signs (blood pressure and pulse rate)
Time frame: Day 1 to 14
CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax
Time frame: Day 7
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Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
DeLand, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Honolulu, Hawaii, United States
Pfizer Investigational Site
Wichita, Kansas, United States
...and 2 more locations