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This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 50 mg x 1 dose |
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| Cohort 2 | Experimental | 100 mg x 1 dose |
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| Cohort 3 | Experimental | 150 mg x 1 dose |
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| Cohort 4 | Experimental | 200 mg x 1 dose |
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| Cohort 5 | Experimental | 150 mg + 100 mg x 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylone | Drug | Oral dose of methylone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for methylone | 48 hours following the dose | |
| AUC: Area under the plasma concentration-time curve for methylone | 48 hours following the dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and frequency of adverse events | 10 days after the dose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C400939 | methylone |
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Subjects will be enrolled into one of four cohorts. The study will begin enrolling Cohort 1.
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| Placebo | Drug | Placebo to match methylone |
|