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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00576589 |
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 |
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Obesity Cholelithiasis |
Drug: CE-326,597 Drug: Placebo |
Phase I |
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 |
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.
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Placebo: Placebo Comparator |
Drug: Placebo
CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
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 |
Safety in patients with Asymptomatic cholelithiasis/gallstones. |
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 |