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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
76
risperidone daily for 28 days
mifepristone daily for 28 days
risperidone-matched placebo daily for 28 days
Dhirubhai Ambani Life Sciences Centre
Mumbai, India
Change From Baseline in Body Weight
Time frame: Baseline and 28 days
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Time frame: Baseline and 28 days
Percentage of Participants With One or More Adverse Events
Time frame: Up to 28 days
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Time frame: Up to 28 days
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mifepristone-matched placebo daily for 28 days