AL001 vs Lithium Carbonate Phase 1 Bipolar I Disorder Trial
ClinicalTrials.gov Studies
Summary
NIH registered Phase 1 trial NCT07540338 to assess safety and brain/plasma pharmacokinetics of investigational drug AL001 (a crystallized lithium formulation) compared to marketed immediate-release lithium carbonate in subjects with Bipolar I Disorder. The crossover study will enroll participants who take each drug for 14-day periods at MGH research unit with MRI and blood draw monitoring. No compliance obligations are imposed by this registry entry.
What changed
NIH registered a new Phase 1 clinical trial (NCT07540338) on ClinicalTrials.gov comparing investigational drug AL001 to standard lithium carbonate in Bipolar I Disorder patients. The crossover study will evaluate safety and pharmacokinetics over two 14-day treatment periods with MRI and blood draw monitoring at MGH. Trial sponsors and clinical investigators conducting psychiatric drug studies should note this comparative bioequivalence/bioavailability design for lithium-based therapeutics in bipolar populations.
Affected parties include clinical research organizations, psychiatric trial sponsors, and bipolar disorder patient advocacy groups following new therapeutic candidates. The trial represents standard Phase 1 comparative safety work and does not create regulatory obligations for non-participating entities.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Phase 1 NCT07540338 Kind: PHASE1 Apr 20, 2026
Abstract
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: Bipolar I Disorder
Interventions: AL001, Lithium carbonate
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.