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Effect of a CCK-1R Agonist on Food Intake in Humans (GSK)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00600743
First received: January 14, 2008
Last updated: March 3, 2010
Last verified: March 2010
  Purpose

The ultimate aim of this study is to test the hypothesis that the oral CCK agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia Nervosa. The study will be conducted in phases. First, an effective dose for reducing food intake, when normal subjects eat normally will be attained. Next, it will be determined whether intake at this dose is reduced in control subjects instructed to eat to capacity. If the dose is still effective compared to placebo, the same dose will be tested in patients with bulimia nervosa.


Condition Intervention Phase
Bulimia Nervosa
Normal Subjects Eating to Satiation
Normal Subjects Overeating
Drug: GSKI181771X (CCK-1R agonist)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of a CCK-1R Agonist on Food Intake in Humans

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Significant reduction in food intake by drug compared to placebo [ Time Frame: 25-30 min after taking drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Significant increase in satiation after drug compared to placebo [ Time Frame: 25-30 min after taking drug ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Normal group
Drug: GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo
Other Name: GSKI181771X
2
Patients with bulimia nervosa
Drug: GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo
Other Name: GSKI181771X

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both controls and patients will be female, 18 to 45 years old, and within 80-120% of ideal body weight (Metropolitan Life Insurance, 1983). Inclusion and exclusion will be evaluated using the following guidelines:

Normal Controls:

  • No current or past psychiatric illness
  • No history of binge eating or vomiting
  • 80-120% ideal weight
  • Of non-childbearing potential (i.e. physiologically incapable of becoming pregnant or surgically sterile)
  • If of childbearing potential, willing to use an acceptable method of birth-control (please see list in "Exclusion" section)

Patients with Bulimia Nervosa:

  • DSM-IV criteria for bulimia nervosa
  • Duration of illness > 1 year
  • Purging after binges via self-induced vomiting

(Same as controls for remaining inclusion criteria)

Exclusion Criteria:

Normal Controls:

  • Significant medical illness: CBC, Chem-1, serum electrolytes (sodium, potassium, chloride, CO2), glucose, BUN, creatinine, Alk Phos, ALT (SGPT), AST (SGOT), LDH, total bilirubin, total protein, albumin, globulin, A/G ratio, calcium, phosphorus, uric acid, cholesterol, triglyceride
  • ALT outside of upper limit of normal: Chem-1
  • History of gallstones, pancreatitis or cholecystitis
  • Current medication
  • Hypersensitivity to benzodiazepines (contraindication in DCSI v02, 1-March-2006)
  • Drug or alcohol abuse in last 3 mts
  • Pregnancy
  • Unable or unwilling to use highly effective methods of contraception for the duration of the study until an insignificant amount of the investigational product remains in the subject (i.e. at least 5 terminal phase half-lives). Examples of highly effective methods of contraception are:

    • Implants of levonorgestrel, or
    • Injectable progestogen, or
    • Oral birth control pills for at least 3 monthly cycles prior to administration of study drug + continuation for 24 hrs after last dose of study drug, or
    • Double-barrier method (e.g. condom, diaphragm) with spermicide

Note-Significant medical illness is any illness requiring continued care, i.e. chronic medication. Examples include hypertension, diabetes, and systemic lupus erythematosis. Subjects with seasonal allergies or occasional urinary tract infections will be included.

Patients with Bulimia Nervosa:

  • Same as controls
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600743

Locations
United States, New York
St. Luke's/Roosevelt Hospital
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
GlaxoSmithKline
Investigators
Principal Investigator: Harry R. Kissileff, Ph.D. St. Luke's-Roosevelt Hospital Center
Study Director: Jeanine Albu, MD St. Luke's-Roosevelt Hospital Center
  More Information

Additional Information:
No publications provided

Responsible Party: Harry R. Kissileff, St. Luke's/Roosevelt Hospital
ClinicalTrials.gov Identifier: NCT00600743     History of Changes
Other Study ID Numbers: 07-101
Study First Received: January 14, 2008
Last Updated: March 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Eating
Food Intake
Appetite

Additional relevant MeSH terms:
Bulimia Nervosa
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014