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NCT05049343 · ClinicalTrials.gov registry record · Phase 1
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
A Phase 1 study of Healthy Volunteer, sponsored by Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05049343: Completed Phase 1 study of Healthy Volunteer, sponsored by Supernus Pharmaceuticals.
NCT05049343 is a Phase 1 study of Healthy Volunteer that has completed, run by Supernus Pharmaceuticals. The registered enrollment target is 22 participants, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05049343, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.
Primary Outcome
AEP variables will include individual amplitudes of N100 and P200 responses and the derived peak-to-peak amplitude of these responses (N100-P200) in microvolts (µV).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG SAGE-904
Study Locations (1)
New Jersey
- Sage Investigational Site - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2021-12-03 |
| Phase | Phase 1 |
What the finished NCT05049343 record still lists
NCT05049343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 202-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05049343 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05049343 about?
NCT05049343 is a clinical study titled "Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants". The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.
What is the current status of trial NCT05049343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-09-21. Estimated completion is 2021-12-03.
What conditions does trial NCT05049343 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT05049343?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), SAGE-904 (DRUG).
Who is sponsoring clinical trial NCT05049343?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05049343 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05049343's enrollment target sits among peer trials
22 94th of 112 higher than 19 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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