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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 Subjects With Bipolar I Disorder

NCT07540338 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

AL001

Crystallized lithium

DRUG

Lithium carbonate

Lithium carbonate

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT07540338 on ClinicalTrials.gov