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This study is a phase 1, double-blind, placebo-controlled crossover study of single, oral dose of SAGE-718 using a ketamine challenge, to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAGE-718 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAGE-718 | Drug | SAGE-718 in combination with Ketamine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the electrophysiological parameters, auditory evoked potentials, between pre- and post-ketamine infusion in subjects receiving SAGE-718 vs the change in parameters between pre- and post-ketamine infusion in subjects receiving placebo | Between Day 1 and Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by the incidence of adverse events (AEs)/serious AEs (SAEs). | Between Baseline and Day 27 | |
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in 12-lead electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Long Beach | California | 90806 | United States | ||
| Sage Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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| Placebo | Drug | Placebo in combination with Ketamine |
|
Observed values and change from baseline in ECGs in patients post study drug administration |
| Between Baseline and Day 12 |
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in electroencephalograms (EEGs) including Delta, Theta, Alpha, Beta. | Observed values and change from baseline in EEGs in patients post study drug administration | Between Baseline and Day 12 |
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS). | Between Baseline and 27 days |
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Brief Psychiatric Rating Scale (BPRS). | Between Day 1 and Day 11 |
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Clinician Administered Dissociative State Scale (CADSS). | Between Day 1 and Day 11 |
| Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Observer's Assessment of Alertness and Sedation (OAAS). | Between Day 1 and Day 11 |
| Berlin |
| New Jersey |
| 08009 |
| United States |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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