NCT06921590

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 Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability 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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Alzamend Neuro, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Detailed description

This study is researching the effects of a new type of crystalized lithium, AL001, on it's ability to reach the brain and have an effect. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the crystalized lithium can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with crystalized lithium when compared to commonly used lithium. This past research suggests that crystallized lithium may be more effective, potentially allowing for lower doses and fewer side effects. If successful, this new form of lithium could offer a new and safe treatment option for psychiatric and neurological disorders. This study involves two, 2-week long overnight stays at the main campus of Massachusetts General Hospital. During these stays participants will receive lithium carbonate for one stay and the crystalized lithium for the other. There are frequent blood draws and brain MRI scans during two periods of the study to look at how the crystalized lithium is broken down in the body and to see how it reaches the brain. This study will compare AL001 to a study reference treatment of lithium carbonate. The majority of the blood draws and MRIs will occur over a 24 hour period during each 2-week long overnight stay at MGH.

Conditions

• Pharmacokinetics
• Neurology

Interventions

Type	Name	Description
DRUG	AL001	Crystalized Lithium
DRUG	Lithium Carbonate Capsule	Lithium Carbonate

Timeline

• Start date: 2025-05-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-04-10
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study