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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CE-326,597

Group Type EXPERIMENTAL

CE-326,597

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.

Interventions

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CE-326,597

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.

Intervention Type DRUG

Placebo

CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes