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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

NCT06921590 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-09

No results posted yet for this 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

Interventions

DRUG

AL001

Crystalized Lithium

DRUG

Lithium Carbonate Capsule

Lithium Carbonate

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Alzamend Neuro, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06921590 on ClinicalTrials.gov