A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Phase 1

Completed

Interventions: Drug: Risperidone
Drug: Mifepristone
Drug: Risperidone-matched placebo
Drug: Mifepristone-matched placebo

Brief Summary: This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

Detailed Description: This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.

Recruitment & Eligibility

Inclusion Criteria

BMI ≥ 18 and ≤ 23 kg/m2
Able to provide written informed consent
Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
AST, ALT, Tbili within normal limits at screening
Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study
Agree to use a barrier method of birth control for 28 days following the last dose of study medication
Have maintained a stable weight for at least 6 months prior to Screening

Exclusion Criteria

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 drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician
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 risperidone
Any other clinically significant abnormality on screening laboratory tests
QTc Bazzett's ≥ 450 msec
History of or current 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
Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism
Any personal or family history of Neuroleptic Malignant Syndrome

Arm && Interventions

Group	Intervention	Description
Risperidone-matched placebo plus mifepristone	Risperidone-matched placebo	risperidone-matched placebo plus mifepristone daily for 28 days
Risperidone plus mifepristone-matched placebo	Risperidone	risperidone plus mifepristone-matched placebo daily for 28 days
Risperidone-matched placebo plus mifepristone	Mifepristone	risperidone-matched placebo plus mifepristone daily for 28 days
Risperidone plus mifepristone-matched placebo	Mifepristone-matched placebo	risperidone plus mifepristone-matched placebo daily for 28 days
Risperidone plus mifepristone	Risperidone	risperidone plus mifepristone daily for 28 days
Risperidone plus mifepristone	Mifepristone	risperidone plus mifepristone daily for 28 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Baseline and 28 days

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight	Baseline and 28 days
Percentage of Participants Discontinued From the Study Due to an Adverse Event	Up to 28 days
Percentage of Participants With One or More Adverse Events	Up to 28 days