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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: CE-326,597; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576589

A7211006

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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41 participants in 2 patient groups, including a placebo group

CE-326,597

Experimental group

Treatment:

Drug: CE-326,597

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo