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

NCT00576589 | Completed Phase 1

• 1 other identifier: A7211006
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

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.

Conditions

Obesity

Keywords

Safety in patients with Asymptomatic cholelithiasis/gallstones.

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

CE-326,597

EXPERIMENTAL

Drug: CE-326,597

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

CE-326,597

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Pfizer Investigational Site

Anniston, Alabama, 36201, United States

Location

Pfizer Investigational Site

Anniston, Alabama, 36207, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

DeLand, Florida, 32720, United States

Location

Pfizer Investigational Site

Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Honolulu, Hawaii, 96813, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67214, United States

Location

Pfizer Investigational Site

Madisonville, Kentucky, 42431, United States

Location

Pfizer Investigational Site

Willingboro, New Jersey, 08046, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity; Gallstones

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: January 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 18, 2010

Record last verified: 2008-11

Locations

US (12)