Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones

A Phase 1, 2-Part, Randomized, Subject And Investigator Blinded, Placebo-Controlled, Cross-Over Trial To Evaluate The Safety, Tolerability And Pharmacokinetics Of CE-326,597 In Obese, Adult Subjects With Asymptomatic Cholelithiasis

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.

Inclusion Criteria:

• Body Mass Index between 30-40 kg/m2, inclusive
• Evidence of asymptomatic cholelithiasis on screening abdominal ultrasound

Exclusion Criteria:

• Patients with unstable medical conditions, such as diabetes, stroke, heart attack.
• Females of childbearing potential or those who may be pregnant or breast feeding.
• Patients with inflammed gallbladder, evidence of stones in bile ducts on screening abdominal ultrasound, history of symptoms indicating active gallbladder disease or gallbladder removal.