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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 is a Phase 1 study that is actively recruiting participants, run by Alzamend Neuro. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07540338
The ClinicalTrials.gov registry entry for NCT07540338 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alzamend Neuro, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AL001 is the first listed.
NCT07540338 reports 0 study locations.
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.
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