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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: Active Phase 1 study of Pharmacokinetics and Neurology, sponsored by Alzamend Neuro.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
• Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters.
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 |
What the registry record for NCT06921590 still lists
NCT06921590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT06921590's enrollment target sits among peer trials
6 37th of 37 the lowest of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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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