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This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using 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 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo | From Day 1 through Day 11 | |
| Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo | From Day 1 through Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. | Between Baseline and Day 26 |
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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 |
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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| Drug |
Placebo in combination with Ketamine |
|
| Berlin |
| New Jersey |
| 08009 |
| United States |