A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corcept Therapeutics
• Collaborator: Eli Lilly and Company
• Treatments: Mifepristone; Olanzapine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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