Status:
COMPLETED
A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain
Lead Sponsor:
Corcept Therapeutics
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Weight-Gain Prevention
Eligibility:
MALE
18-40 years
Phase:
PHASE2
Brief Summary
This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.
Eligibility Criteria
Inclusion
- Healthy male volunteers between 18 and 40 years of age
- BMI between ≥ 18 and ≤ 25
- Able to provide written informed consent
- Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
Exclusion
- History of Cushing's syndrome or Addison's disease
- Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
- Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
- Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
- Have a history of an allergic reaction to either mifepristone or olanzapine
- Any clinically significant abnormality on screening laboratory tests
- QTc Bazzett's ≥ 450 msec
- Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
- Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
- History of recent (within 6 months of screening) significant weight fluctuation
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00455442
Start Date
March 1 2007
End Date
July 1 2007
Last Update
September 19 2008
Active Locations (1)
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1
St. John's Medical College
Bangalore, India