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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CE-326,597
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Safety in patients with Asymptomatic cholelithiasis/gallstones.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CE-326,597

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2007
Last Updated
January 14, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00576589
Brief Title
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Safety in patients with Asymptomatic cholelithiasis/gallstones.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CE-326,597
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CE-326,597
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
Primary Outcome Measure Information:
Title
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
Title
CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
Facility Name
Pfizer Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Pfizer Investigational Site
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7211006&StudyName=Study%20Of%20The%20Safety%20And%20Pharmacokinetics%20Of%20CE-326%2C597%20In%20Patients%20With%20Asymptomatic%20Gallstones
Description
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Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones

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