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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00576589
First received: December 17, 2007
Last updated: January 14, 2010
Last verified: November 2008
  Purpose

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 Intervention Phase
Obesity
Drug: CE-326,597
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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) [ Time Frame: Day 1 to 14 ] [ Designated as safety issue: Yes ]
  • CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2008
Study Completion Date: September 2008
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576589

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00576589     History of Changes
Other Study ID Numbers: A7211006
Study First Received: December 17, 2007
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014