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Also known as RDC-0313 (ALKS 33)
RDC-0313 · 2 trials · 2 indications
A TEAE is any adverse event (AE), regardless of causality, that either: begins after a participant's first dose of study drug, up to and including the final follow-up visit; or started before a participant's first dose of study drug but worsens in severity after the first dose of study drug, up to and including the final follow-up visit.
| Arm | Type | Description |
|---|---|---|
| RDC-0313 (ALKS 33) | EXPERIMENTAL | 2-capsules taken orally |
| Placebo | PLACEBO_COMPARATOR | 2-capsules taken orally |
| RDC-0313, 5mg | EXPERIMENTAL | 5 mg of RDC-0313; single dose |
| RDC-0313, 15 mg | EXPERIMENTAL | 15 mg RDC-0313; single dose |
| RDC-0313, 25mg | EXPERIMENTAL | 25 mg RDC-0313; single dose |
| RDC-0313, 50 mg | EXPERIMENTAL | 50 mg RDC-0313; single dose |
| RDC-0313, 75 mg | EXPERIMENTAL | 75 mg RDC-0313; single dose |
| Name | Type | Description |
|---|---|---|
| RDC-0313 (ALKS 33) | DRUG | Capsules for daily oral administration |
| Placebo | DRUG | Capsules containing lactose and no active drug for daily oral administration |
| RDC-0313 | DRUG | Oral solution given in 5, 15, 25, 50, and 75 mg single doses |
Inclusion Criteria: * Meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revised (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED) * Display greater than or equal to 3 binge eating days per week * Body mass index (BMI) greater than or equal to 30 kg/...
RDC-0313 is an investigational small molecule being developed by Alkermes plc for alcohol dependence and binge eating disorder. It is in Phase 1 clinical development and has been studied in completed trials, including a Phase 2 trial in adults with binge eating disorder and a Phase 1 trial in healthy adults.
RDC-0313 is being studied for the treatment of alcohol dependence and binge eating disorder. Clinical trials have evaluated it in adults with binge eating disorder and in healthy adults in the context of alcohol dependence research. It is not approved for any indication and remains investigational.
RDC-0313 is being developed by Alkermes plc, which trades on the Nasdaq under the ticker ALKS. Alkermes is the sponsor of the clinical trials evaluating the drug in alcohol dependence and binge eating disorder.
RDC-0313 is in Phase 1 clinical development. One completed Phase 1 trial and one completed Phase 2 trial have been conducted. The drug is investigational and has not been approved by the FDA for any indication.
RDC-0313 has been evaluated in two completed trials: NCT01098435, a Phase 2 study in adults with binge eating disorder that enrolled 69 participants, and NCT00800319, a Phase 1 study in healthy adults that enrolled 16 participants. Both trials were conducted in the United States.
Yes, RDC-0313 is also known as ALKS 33. Both names refer to the same investigational compound developed by Alkermes plc for alcohol dependence and binge eating disorder.