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

Completed · Phase 1 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00576589

Run by

Pfizer

People needed

41

Starts

2008-01-01

Expected to finish

2008-09-01

Last updated by the study team

2010-01-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index between 30-40 kg/m2, inclusive
• Evidence of asymptomatic cholelithiasis on screening abdominal ultrasound

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Anniston, Alabama, United States
• Pfizer Investigational Site — Anniston, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — South Miami, Florida, United States
• Pfizer Investigational Site — Honolulu, Hawaii, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Madisonville, Kentucky, United States
• Pfizer Investigational Site — Willingboro, New Jersey, United States

Full record on ClinicalTrials.gov

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