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NCT03770780
A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
Phase 1 trial testing SAGE-718 in Healthy Volunteer in 19 participants. Completed in 22 March 2019.
8 March 2019
Quick facts
| Lead sponsor | Supernus Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 19 |
| Start date | 12 November 2018 |
| Primary completion | 8 March 2019 |
| Estimated completion | 22 March 2019 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- SAGE-718 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Supernus Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic response using magnetic resonance imaging in healthy subjects
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03770780
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SAGE-718
Trials testing the same drug.
- NCT05655520 — A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease · Phase 3 · terminated
- NCT05619692 — A Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzhe · Phase 2 · completed
- NCT05318937 — A Study to Evaluate the Effects of SAGE-718 in Participants With Parkinson's Disease Cognitive Impairment · Phase 2 · completed
- NCT05358821 — 28-Day Study of SAGE-718 on Functioning Capacity in Participants With Huntington's Disease · Phase 2 · completed
- NCT05107128 — A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD) · Phase 2 · completed
Other recruiting trials for Healthy Volunteer
Currently open trials in the same condition.
- NCT06274749 — Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Mask · NA · recruiting
- NCT05652478 — Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study · Phase 2 · recruiting
- NCT06845176 — Combining Motor Imagery and Tendon Vibration on the Effectiveness of Motor Imagery · NA · recruiting
- NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
- NCT07220122 — Impact of Exogenous Ketones on Breathing in Healthy Volunteers · EARLY_PHASE1 · recruiting
Other Supernus Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07226661 — Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder · Phase 2 · recruiting
- NCT07141329 — SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07219927 — Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: · recruiting
- NCT06185985 — Open-label Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD and Mood Symptoms · Phase 4 · completed
- NCT06259331 — Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03770780 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc.
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03770780.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing