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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...
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Basimglurant is an investigational small molecule being studied for the treatment of major depressive disorder. It has been evaluated in a Phase 1 clinical trial that included patients with major depressive disorder and healthy volunteers. Basimglurant is not approved for any indication and remains in clinical development.
Basimglurant targets GRM5, also known as the metabotropic glutamate receptor 5. It acts as a modulator of this receptor. By targeting GRM5, basimglurant is designed to influence glutamatergic signaling, which is being explored in major depressive disorder.
Basimglurant is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating basimglurant for major depressive disorder.
Basimglurant is in Phase 1 clinical development. It has not been approved by the FDA or any regulatory agency. The completed Phase 1 trial was designed to assess safety, tolerability, and pharmacokinetics in healthy subjects and patients with major depressive disorder.
Basimglurant has been studied in one completed Phase 1 trial, NCT02433093. This trial was a multiple-ascending dose study of the safety, tolerability, and pharmacokinetics of basimglurant in healthy subjects and patients with major depressive disorder. It enrolled 56 participants in the United States.
Basimglurant is also known by the code name RO4917523. Both names refer to the same investigational small molecule developed by Roche Holding AG for major depressive disorder.