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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576589

Enrollment

Registered

2007-12-19

Start date

2008-01-31

Completion date

2008-09-30

Last updated

2010-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Safety in patients with Asymptomatic cholelithiasis/gallstones.

Brief summary

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.

Interventions

DRUGCE-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.

DRUGPlacebo

CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026