Trials / Completed
CompletedNCT05049343
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
A Phase 1, Double-Blind, Placebo-Controlled Crossover Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Supernus Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAGE-904 | SAGE-904 oral solution. |
| DRUG | Placebo | Placebo oral solution. |
| DRUG | Ketamine | Ketamine intravenous (IV) infusion. |
Timeline
- Start date
- 2021-09-21
- Primary completion
- 2021-11-20
- Completion
- 2021-12-03
- First posted
- 2021-09-20
- Last updated
- 2025-09-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05049343. Inclusion in this directory is not an endorsement.