Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(Drug expired before was completed.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00600743
First received: January 14, 2008
Last updated: April 26, 2017
Last verified: April 2017
  Purpose
The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (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
Drug: GSKI181771X (CCK-1R agonist)
Behavioral: Instructions to binge eat
Behavioral: Instructions to eat normally
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, 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:
  • Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions [ Time Frame: 25-30 min after taking drug ]
    Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions


Secondary Outcome Measures:
  • Fullness Rating [ Time Frame: 25-30 min after taking drug ]
    rating of "How full do you feel" by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable).

  • Sickness Report [ Time Frame: 25-30 min after drug or placebo ]
    Response to question "How sick do you feel" measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)


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
Placebo Comparator: 1 'Instructions to eat normally'
'Instructions to eat normally' Placebo 1 mg dose
Behavioral: Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo
Drug: Placebo
Drug one trial vs placebo
Active Comparator: 2 'Instructions to eat normally'
'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)'
Drug: GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo
Other Name: GSKI181771X
Behavioral: Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo
Placebo Comparator: 3 'Instructions to eat normally'
'Instructions to eat normally' 2 mg placebo
Behavioral: Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo
Drug: Placebo
Drug one trial vs placebo
Active Comparator: 4 'Instructions to eat normally'
'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)'
Drug: GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo
Other Name: GSKI181771X
Behavioral: Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo
Placebo Comparator: 5 'Instructions to eat normally'
'Instructions to eat normally' 4 mg placebo
Behavioral: Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo
Drug: Placebo
Drug one trial vs placebo
Active Comparator: 6 'Instructions to eat normally'
'Instructions to eat normally' 4 mg drug 'GSKI181771X (CCK-1R agonist)'
Drug: GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo
Other Name: GSKI181771X
Behavioral: Instructions to eat normally
Subjects will be instructed to eat normally and will also be given either drug or placebo
Placebo Comparator: 7 Instructions to binge eat
Instructions to binge eat 4 mg placebo
Behavioral: Instructions to binge eat
Subjects will be instructed to binge eat and will also be given either drug or placebo
Drug: Placebo
Drug one trial vs placebo
Active Comparator: 8 Instructions to binge eat
Instructions to binge eat 4 mg drug 'GSKI181771X (CCK-1R agonist)'
Drug: GSKI181771X (CCK-1R agonist)
Drug one trial vs placebo
Other Name: GSKI181771X
Behavioral: Instructions to binge eat
Subjects will be instructed to binge eat and will also be given either drug or placebo

Detailed Description:
This study tests the hypothesis that an oral CCK antagonist GSKI181771X will reduce the size of a binge meal. It was intended to study the effects of increasing doses on antagonist on normal individuals to find an effective dose in a non-binge meal before moving to a binge meal. Once the effects of the antagonist on a binge meal were found, the compound would be used on patients with bulimia nervosa. However, the product expired and more was not available before the patients were tested. Data are presented for the normal participants who were instructed to eat normally, followed by a group that was instructed to binge eat. Comparisons were made between groups with different instructions and between binge and normal meals.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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 (diagnostic statistical manual - American Psychiatric Association) 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 (blood urea nitrogen), 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:
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00600743     History of Changes
Other Study ID Numbers: 07-101
Study First Received: January 14, 2008
Results First Received: February 21, 2011
Last Updated: April 26, 2017

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

Additional relevant MeSH terms:
Bulimia
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017