Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Samidorphan · 2 trials · 2 indications
Area under the concentration time curve of total radioactivity from time 0 to last observed concentration in blood and plasma
Maximum concentration of total radioactivity in blood and plasma
Time to maximum concentration of total radioactivity in blood and plasma
Fraction of dose excreted in urine and feces
| Arm | Type | Description |
|---|---|---|
| Samidorphan IV | EXPERIMENTAL | Samidorphan solution for IV administration |
| Samidorphan sublingual | EXPERIMENTAL | \[14c\]-Samidorphan for sublingual administration |
| Samidorphan oral | EXPERIMENTAL | \[14c\]-Samidorphan for oral administration |
| Samidorphan Dose 1 | EXPERIMENTAL | - |
| Samidorphan Dose 2 | EXPERIMENTAL | - |
| Samidorphan Dose 3 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Oxycodone Dose 1 | ACTIVE_COMPARATOR | - |
| Oxycodone Dose 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Samidorphan IV | DRUG | Single IV administration |
| [14c]-Samidorphan sublingual | DRUG | Single sublingual administration containing radiolabel |
| [14c]-Samidorphan oral | DRUG | Single oral administration containing radiolabel |
| Samidorphan | DRUG | - |
| Placebo | DRUG | - |
| Oxycodone | DRUG | - |
Inclusion Criteria: * Body mass index (BMI) of greater than/equal to 19 and less than/equal to 32 kg/m\^2 at screening (minimum weight of 50.0 kg) * Generally good health * Subjects must agree to reduce the risk of a female partner becoming pregnant during the study and for 30 days after the last d...
Samidorphan is an investigational small molecule being studied in schizophrenia and alcohol use disorder. It is also being evaluated in healthy volunteers for abuse liability and drug metabolism studies. The drug is not approved and remains in clinical development.
Samidorphan 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 schizophrenia and related conditions.
Samidorphan is in Phase 1 clinical development. While some completed trials were Phase 2, the most recent and ongoing development stage is Phase 1. The drug is investigational and has not been approved by regulatory authorities.
Samidorphan has been studied in several completed trials, including NCT01903837 in schizophrenia, NCT02161718 in schizophrenia with alcohol use disorder, NCT02218021 in healthy recreational opioid users, and NCT02504463 in healthy male volunteers. All trials are completed.
Samidorphan is also known as ALKS 33. In clinical trials, it has been studied under the name ALKS 3831, which appears to be a combination or formulation of the drug. The trials NCT01903837 and NCT02161718 used the ALKS 3831 designation.