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NCT06921590 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
A Phase 1 study of Pharmacokinetics and Neurology, sponsored by Alzamend Neuro.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT06921590 is a Phase 1 study of Pharmacokinetics and Neurology that is active but no longer recruiting, run by Alzamend Neuro. The registered enrollment target is 6 participants, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06921590, a Phase 1 study of Pharmacokinetics and Neurology, is active but no longer recruiting, sponsored by Alzamend Neuro.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate? Participants will be asked to: * Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days * Stay overnight at MGH's research unit for two separate 2-week periods * Participate in two separate 24 hour periods of multiple MRIs and blood draws
Conditions Studied
Interventions
- DRUG AL001
- DRUG Lithium Carbonate Capsule
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2025-05-09 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06921590
The ClinicalTrials.gov registry entry for NCT06921590 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (90% lower). The listed sponsor is Alzamend Neuro, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which AL001 is the first listed.
NCT06921590 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06921590 about?
NCT06921590 is a clinical study titled "A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects". The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? ...
What is the current status of trial NCT06921590?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2025-05-09. Estimated completion is 2025-12.
What conditions does trial NCT06921590 study?
This clinical trial studies the following conditions: Pharmacokinetics, Neurology.
What interventions are being tested in trial NCT06921590?
The interventions under investigation include: AL001 (DRUG), Lithium Carbonate Capsule (DRUG).
Who is sponsoring clinical trial NCT06921590?
This trial is sponsored by Alzamend Neuro, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06921590 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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