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

January 14, 2010 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pfizer Investigational Site
      • Anniston, Alabama, United States, 36201
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32809
        • Pfizer Investigational Site
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
Experimental: CE-326,597
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 to 14
CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

January 18, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7211006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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