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
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Bipolar I Disorder
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1/2
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Alzamend Neuro, Inc.
- Last updated on ClinicalTrials.gov
- July 28, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Massachusetts · 1
- Massachusetts General Hospital · Boston, MA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.