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NCT07540338 · 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 Subjects With Bipolar I Disorder
A Phase 1 study, sponsored by Alzamend Neuro.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT07540338: Recruiting Phase 1 study, sponsored by Alzamend Neuro.
NCT07540338 is a Phase 1 study that is actively recruiting participants, run by Alzamend Neuro. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07540338, a Phase 1 study, is actively recruiting participants, sponsored by Alzamend Neuro.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are: * How safe 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.
Interventions
- DRUG AL001
- DRUG Lithium carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-04 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT07540338 shows while recruiting
NCT07540338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which AL001 is the first listed.
NCT07540338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07540338 about?
NCT07540338 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 Subjects With Bipolar I Disorder". The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are: * How safe is AL001 when compared to lit...
What is the current status of trial NCT07540338?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2026-04. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07540338?
The interventions under investigation include: AL001 (DRUG), Lithium carbonate (DRUG).
Who is sponsoring clinical trial NCT07540338?
This trial is sponsored by Alzamend Neuro, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07540338's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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