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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: CE-326,597; Drug: Placebo

• Registration Number: NCT00576589
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-19
• Study Start: 2008-01
• Study Completion: 2008-09
• Status Verified: 2008-11
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CE-326,597	CE-326,597	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability assessed via AEs/SAEs, plus where applicable gastrointestinal symptoms checklist, clinical laboratory tests, vital signs (blood pressure and pulse rate)	Day 1 to 14
CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax	Day 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Willingboro, New Jersey, United States