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NCT04711005 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT04711005: Completed Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT04711005 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04711005, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 2-cohort multiple ascending dose (MAD) study will be conducted. Doses will be administered on days 1, 4, 8, and 11. Standard safety parameters will be monitored, and PK will be evaluated at all dose levels. Finally, a single-cohort group with received a single dose by slow-infusion IV and have PK samples collected from both blood and cerebrospinal fluid (CSF).
Primary Outcome
Investigational product-related adverse events and serious adverse events
Interventions
- DRUG Placebo
- DRUG (2R,6R)-Hydroxynorketamine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 1 |
What the finished NCT04711005 record still lists
NCT04711005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04711005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04711005 about?
NCT04711005 is a clinical study titled "Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine". A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 2-cohort multiple ascending dose (...
What is the current status of trial NCT04711005?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2021-01-11. Estimated completion is 2023-05-31.
What interventions are being tested in trial NCT04711005?
The interventions under investigation include: Placebo (DRUG), (2R,6R)-Hydroxynorketamine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04711005?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04711005's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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