Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00576589
First received: December 17, 2007
Last updated: January 14, 2010
Last verified: November 2008
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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
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. |
Additional relevant MeSH terms:
|
Cholelithiasis Obesity Biliary Tract Diseases Digestive System Diseases Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013