Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MIN-101 · 3 trials · 2 indications
To estimate the relative bioavailability of MIN-l0l following MIN-101 administration. Plasma samples will be analyzed for MIN-101 and its metabolites using a validated LC-MS/MS method
To estimate the relative bioavailability of MIN-l0l following MIN-101 administration. Plasma samples will be analyzed for MIN-101 and its metabolites using a validated LC-MS/MS method
To estimate the relative bioavailability of MIN-101 and its main metabolites following the administration of the selected modified release formulation in different food conditions (fasted or fed state).
| Arm | Type | Description |
|---|---|---|
| Extensive Metabolizers, 4 mg | EXPERIMENTAL | subjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution |
| Extensive Metabolizers, 8 mg | EXPERIMENTAL | subjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution |
| Extensive Metabolizers, 16 mg | EXPERIMENTAL | subjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution |
| Poor Metabolizers, 4 mg | EXPERIMENTAL | subjects will receive 32 mL of MIN-101 as a 0.125 mg/mL oral solution |
| Poor Metabolizers, 8 mg | EXPERIMENTAL | subjects will receive 32 mL of MIN-101 as a 0.25 mg/mL oral solution |
| Poor Metabolizers, 16 mg | EXPERIMENTAL | subjects will receive 32 mL of MIN-101 as a 0.5 mg/mL oral solution |
| Regimen A | EXPERIMENTAL | 32 mg MIN-101 of the current modified-release formulation (comparator) identified as MR-32 formulation administered in the fasted state |
| Regimen B | EXPERIMENTAL | 32 mg MIN-101 MR administered in the fasted state |
| Regimen C | EXPERIMENTAL | 32 mg MIN-101 MR administered in the fasted state |
| Part 2 selected dose | EXPERIMENTAL | 32 mg MIN-101 of MR administered in the fed state |
| Part 1: MIN-101 | EXPERIMENTAL | MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg |
| Part 2: MIN-101 low dose | EXPERIMENTAL | MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7 |
| Part 2: placebo | PLACEBO_COMPARATOR | placebo MIN-101 daily oral dose from Day 1 to Day 7 |
| Part 2: MIN-101 high dose | EXPERIMENTAL | MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7 |
| Name | Type | Description |
|---|---|---|
| MIN-101 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Confirmed CYP2D6 extensive or poor metabolizer genotype 2. Subject has given voluntary written informed consent before performance of any study related procedure 3. Subject must be 18 to 45 years of age, inclusive 4. Subject must be a healthy male or female as indicated by th...
MIN-101 is an investigational small molecule being studied for schizophrenia and in healthy subjects. It is developed by Minerva Neurosciences, Inc. (NERV). As of now, it has completed Phase 1 clinical trials, and it is not approved by the FDA.
MIN-101 is developed by Minerva Neurosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker NERV. The company is conducting clinical research on this investigational drug for schizophrenia.
MIN-101 is in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials currently ongoing. The drug remains investigational and has not received regulatory approval.
MIN-101 has been studied in three completed Phase 1 trials: NCT02232529, a pharmacokinetic study in healthy subjects in the United Kingdom; NCT03038646, a study of modified release formulations in healthy subjects in Ireland; and NCT03072056, a study comparing metabolism in poor and extensive metabolizers in Ireland.
MIN-101 is also known as roluperidone. It is an investigational small molecule being developed by Minerva Neurosciences for schizophrenia. The drug has completed Phase 1 trials, and its safety and efficacy are still being evaluated.