Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Basimglurant · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Basimglurant: Healthy Cohort (1) | EXPERIMENTAL | Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. Cohort 1 will receive a prespecified titration scheme; however, adaptive titration schemes may be applied in subsequent cohorts. |
| Basimglurant: Healthy Cohort (2) | EXPERIMENTAL | Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 2 will be selected in accordance with decision criteria on the basis of the incidence of severe AEs in Cohort 1. |
| Basimglurant: Healthy Cohort (3) | EXPERIMENTAL | Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 3 will be selected in accordance with decision criteria on the basis of the incidence of severe AEs in preceding Cohorts 1 and 2. |
| Basimglurant: Healthy Cohort (4) | EXPERIMENTAL | Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 4 will be selected in accordance with decision criteria on the basis of the incidence of severe AEs in preceding Cohorts 1, 2, and 3. |
| Basimglurant: MDD Cohort (5) | EXPERIMENTAL | Participants with MDD assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 5 may differ from those previously evaluated; however, the titration steps and the highest dose tested will remain equal to or lower than the doses tested in Cohorts 1 to 4. |
| Placebo: Healthy Cohorts (1 to 4) | PLACEBO_COMPARATOR | Healthy participants will receive a 22-day regimen of matching placebo capsules. |
| Placebo: MDD Cohort (5) | PLACEBO_COMPARATOR | Participants with MDD will receive a 22-day regimen of matching placebo capsules. |
| Name | Type | Description |
|---|---|---|
| Basimglurant | DRUG | Participants will receive once-daily oral basimglurant capsules in a multiple ascending dose regimen. Basimglurant dose will be titrated over 22 days; dose escalations will be separated by at least 4 days, with the final dose administered for a minimum of 14 days. The minimum starting dose will be 1.5 mg, which can be titrated up to a maximum dose of 4.0 mg. Intrapatient dose increments will not exceed 1.0 mg every 4 days. |
| Placebo | DRUG | Participants will receive 22 days of once-daily oral matching placebo capsules. |
Inclusion Criteria: * 18 to 65 years of age, inclusive * Body weight at least 50 kg * Healthy male or female subjects (Healthy Cohorts) * Body mass index (BMI) 18 to 30 kg/m\^2, inclusive (Healthy Cohorts) * Nonsmoker for at least 90 days prior to dosing (Healthy Cohorts) * Primary diagnosis of MDD...
Basimglurant is an investigational small molecule being studied for Major Depressive Disorder (MDD). It has been evaluated in a Phase 1 clinical trial that included healthy volunteers and patients with MDD. The drug is not approved and remains in clinical development.
Basimglurant is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company sponsored the Phase 1 clinical trial of the drug.
Basimglurant is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently listed. The drug is investigational and has not been approved.
Basimglurant has one completed clinical trial, NCT02433093, titled 'A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)'. This Phase 1 trial enrolled 56 participants in the United States.
Yes, the Phase 1 trial of Basimglurant was randomized, double-blind, and placebo-controlled. The study enrolled 56 participants, including healthy volunteers and patients with Major Depressive Disorder.