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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CE-326,597 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-326,597 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed via AEs/SAEs, plus where applicable gastrointestinal symptoms checklist, clinical laboratory tests, vital signs (blood pressure and pulse rate) | Day 1 to 14 | |
| CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anniston | Alabama | 36201 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal. |
|
| Anniston |
| Alabama |
| 36207 |
| United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85013 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32809 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67214 | United States |
| Pfizer Investigational Site | Madisonville | Kentucky | 42431 | United States |
| Pfizer Investigational Site | Willingboro | New Jersey | 08046 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
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