Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for alcohol dependence and binge eating disorder. It is in Phase 1 clinical development for alcohol dependence and has completed a Phase 2 study in binge eating disorder. The drug is not approved and remains under clinical investigation.
RDC-0313 is being developed by Alkermes plc, a biopharmaceutical company traded on NASDAQ under the ticker ALKS. The company is conducting clinical trials of the drug in the United States for psychiatric indications.
RDC-0313 is in Phase 1 clinical development for alcohol dependence. A Phase 2 study in binge eating disorder has been completed. The drug is investigational and has not received regulatory approval for any indication.
RDC-0313 has been studied in two completed clinical trials. NCT00800319 was a Phase 1 study in healthy adults with alcohol dependence, enrolling 16 participants. NCT01098435 was a Phase 2 study in adults with binge eating disorder, enrolling 69 participants. Both trials were conducted in the United States.
Yes, RDC-0313 is also known as ALKS 33. The Phase 2 trial in binge eating disorder, NCT01098435, is titled 'A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder,' confirming the two names refer to the same drug.