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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 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 74 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04711005
The ClinicalTrials.gov registry entry for NCT04711005 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04711005 reports 0 study locations.
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.
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