Healthy
Conditions
Keywords
healthy, weight gain, anti-psychotic, risperidone, mifepristone, mitigation, weight loss
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.
Interventions
DRUGRisperidone
risperidone daily for 28 days
DRUGMifepristone
mifepristone daily for 28 days
DRUGRisperidone-matched placebo
risperidone-matched placebo daily for 28 days
DRUGMifepristone-matched placebo
mifepristone-matched placebo daily for 28 days
Sponsors
Corcept Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Body Weight | Baseline and 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | Baseline and 28 days |
| Percentage of Participants With One or More Adverse Events | Up to 28 days |
| Percentage of Participants Discontinued From the Study Due to an Adverse Event | Up to 28 days |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mifepristone Plus Risperidone mifepristone plus risperidone daily | 30 |
| Risperidone Plus Mifepristone-matched Placebo risperidone plus mifepristone-matched placebo daily | 30 |
| Risperidone-matched Placebo Plus Mifepristone risperidone-matched placebo plus mifepristone daily | 16 |
| Total | 76 |
Baseline characteristics
| Characteristic | Mifepristone Plus Risperidone | Risperidone Plus Mifepristone-matched Placebo | Risperidone-matched Placebo Plus Mifepristone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 16 Participants | 76 Participants |
| Age, Continuous | 24.6 years STANDARD_DEVIATION 3.9 | 25.6 years STANDARD_DEVIATION 3.6 | 24.9 years STANDARD_DEVIATION 4.6 | 25 years STANDARD_DEVIATION 3.9 |
| Body Weight | 57.5 Kilograms STANDARD_DEVIATION 4.1 | 60.4 Kilograms STANDARD_DEVIATION 4.7 | 58.2 Kilograms STANDARD_DEVIATION 4.1 | 58.8 Kilograms STANDARD_DEVIATION 4.5 |
| Region of Enrollment India | 30 participants | 30 participants | 16 participants | 76 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 16 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 16 |
| other Total, other adverse events | 2 / 30 | 3 / 30 | 7 / 16 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 1 / 16 |
Outcome results
Primary
Change From Baseline in Body Weight
Time frame: Baseline and 28 days
Population: All randomized participants who had at least one post baseline assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mifepristone Plus Risperidone | Change From Baseline in Body Weight | 2.32 kilograms | Standard Error 0.32 |
| Risperidone Plus Mifepristone-matched Placebo | Change From Baseline in Body Weight | 4.23 kilograms | Standard Error 0.33 |
| Risperidone-matched Placebo Plus Mifepristone | Change From Baseline in Body Weight | 2.87 kilograms | Standard Error 0.43 |
Secondary
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Time frame: Up to 28 days
Population: All participants who received at lease one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone Plus Risperidone | Percentage of Participants Discontinued From the Study Due to an Adverse Event | 5 Participants |
| Risperidone Plus Mifepristone-matched Placebo | Percentage of Participants Discontinued From the Study Due to an Adverse Event | 4 Participants |
| Risperidone-matched Placebo Plus Mifepristone | Percentage of Participants Discontinued From the Study Due to an Adverse Event | 1 Participants |
Secondary
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Time frame: Baseline and 28 days
Population: All participants who completed the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mifepristone Plus Risperidone | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | <5% increase in body weight | 9 Participants |
| Mifepristone Plus Risperidone | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | <7% increase in body weight | 13 Participants |
| Risperidone Plus Mifepristone-matched Placebo | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | <5% increase in body weight | 3 Participants |
| Risperidone Plus Mifepristone-matched Placebo | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | <7% increase in body weight | 10 Participants |
| Risperidone-matched Placebo Plus Mifepristone | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | <5% increase in body weight | 8 Participants |
| Risperidone-matched Placebo Plus Mifepristone | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | <7% increase in body weight | 11 Participants |
Secondary
Percentage of Participants With One or More Adverse Events
Time frame: Up to 28 days
Population: All participants who received at lease one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mifepristone Plus Risperidone | Percentage of Participants With One or More Adverse Events | 29 Participants |
| Risperidone Plus Mifepristone-matched Placebo | Percentage of Participants With One or More Adverse Events | 27 Participants |
| Risperidone-matched Placebo Plus Mifepristone | Percentage of Participants With One or More Adverse Events | 13 Participants |