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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576589
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : January 18, 2010
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: CE-326,597 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]
  2. CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax [ Time Frame: Day 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576589

United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36201
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Pfizer Investigational Site
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
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67214
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, New Jersey
Pfizer Investigational Site
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00576589     History of Changes
Other Study ID Numbers: A7211006
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: November 2008

Keywords provided by Pfizer:
Safety in patients with Asymptomatic cholelithiasis/gallstones.

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases