A Phase 1 interventional study of CE-326,597 and Placebo in Obesity, sponsored by Pfizer. Completed at 12 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-18.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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.
346 studies on the registry are indexed under Gallstones; 46 are open to participants now.
This study's enrollment of 41 is below the median of 99 across 232 interventional studies indexed under Gallstones.
Browse Gallstones studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: CE-326,597
Drug: Placebo
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.
CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
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
CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax
Time frame: Day 7
This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer