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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00576589

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 Cholelithiasis	Drug: CE-326,597 Drug: Placebo	Phase I

MedlinePlus related topics: Gallstones Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
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

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
CE-326,597: Experimental	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: Placebo Comparator	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

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
Orlando, Florida, United States, 32809
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Miami, Florida, United States, 33143
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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7211006
Study First Received:	December 17, 2007
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00576589
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Safety in patients with Asymptomatic cholelithiasis/gallstones.

Study placed in the following topic categories:

Cholecystolithiasis
Gallbladder Diseases
Pathological Conditions, Anatomical
Obesity
Cholelithiasis
Gallstones
Overweight

Calculi
Body Weight
Signs and Symptoms
Digestive System Diseases
Biliary Tract Diseases
Nutrition Disorders
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009