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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone plus mifepristone | Experimental | risperidone plus mifepristone daily for 28 days |
|
| Risperidone plus mifepristone-matched placebo | Placebo Comparator | risperidone plus mifepristone-matched placebo daily for 28 days |
|
| Risperidone-matched placebo plus mifepristone | Placebo Comparator | risperidone-matched placebo plus mifepristone daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | risperidone daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight | Baseline and 28 days |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Coleman Gross, MD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhirubhai Ambani Life Sciences Centre | Mumbai | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16782211 | Background | Beebe KL, Block T, Debattista C, Blasey C, Belanoff JK. The efficacy of mifepristone in the reduction and prevention of olanzapine-induced weight gain in rats. Behav Brain Res. 2006 Aug 10;171(2):225-9. doi: 10.1016/j.bbr.2006.03.039. Epub 2006 Jun 19. |
| Label | URL |
|---|---|
| Sponsor's Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone Plus Risperidone | mifepristone plus risperidone daily |
| FG001 | Risperidone Plus Mifepristone-matched Placebo | risperidone plus mifepristone-matched placebo daily |
| FG002 | Risperidone-matched Placebo Plus Mifepristone | risperidone-matched placebo plus mifepristone daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone Plus Risperidone | mifepristone plus risperidone daily |
| BG001 | Risperidone Plus Mifepristone-matched Placebo | risperidone plus mifepristone-matched placebo daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Body Weight | All randomized participants who had at least one post baseline assessment. | Posted | Mean | Standard Error | kilograms | Baseline and 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mifepristone Plus Risperidone | mifepristone plus risperidone daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suspected snake bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Roe, MD | Corcept_Therapeutics | 650-688-8812 | rroe@corcept.com |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D015735 | Mifepristone |
| C511997 | Corlux |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Mifepristone | Drug | mifepristone daily for 28 days |
|
|
| Risperidone-matched placebo | Drug | risperidone-matched placebo daily for 28 days |
|
| Mifepristone-matched placebo | Drug | mifepristone-matched placebo daily for 28 days |
|
| Percentage of Participants Discontinued From the Study Due to an Adverse Event |
| Up to 28 days |
| BG002 | Risperidone-matched Placebo Plus Mifepristone | risperidone-matched placebo plus mifepristone daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight | Mean | Standard Deviation | Kilograms |
|
|
|
| Secondary | Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight | All participants who completed the study. | Posted | Count of Participants | Participants | Baseline and 28 days |
|
|
|
| Secondary | Percentage of Participants With One or More Adverse Events | All participants who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| Secondary | Percentage of Participants Discontinued From the Study Due to an Adverse Event | All participants who received at lease one dose of study drug. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Risperidone Plus Mifepristone-matched Placebo | risperidone plus mifepristone-matched placebo daily | 0 | 30 | 0 | 30 | 3 | 30 |
| EG002 | Risperidone-matched Placebo Plus Mifepristone | risperidone-matched placebo plus mifepristone daily | 0 | 16 | 1 | 16 | 7 | 16 |
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| D004963 |
| Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|