Status:
COMPLETED
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Lead Sponsor:
Corcept Therapeutics
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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 det...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00698022
Start Date
November 1 2008
End Date
February 1 2009
Last Update
February 8 2022
Active Locations (1)
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1
Dhirubhai Ambani Life Sciences Centre
Mumbai, India