RecruitingPhase 1/2

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

United States20 participantsStarted 2026-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Subjects with Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by a DSM-5-TR BD1 diagnosis and the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests.
✓. Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of \< 8 and a Hamilton Depression Rating Scale (HDRS-17) rating of \< 16 at the Screening visit and on Day -1 (P1). Subsyndromal depression has not significantly worsened in the 4 weeks prior to randomization on Day -1 (P1) so as to avoid enrolling subjects who are on the verge of a full depressive episode. Assessment of subject's suicidal ideation and behavior (SI/B) using the Columbia-Suicide Severity Rating Scale (C-SSRS) will be conducted to avoid enrolling subjects with concerning results, defined as a lifetime history of a suicide attempt, past year level 4 or higher suicidal ideation on the C-SSRS, or past month suicidal ideation of any kind. The "Lifetime/Recent" version will be used at screening and the "Since Last Visit" version will be used subsequently.
✓. Clinically acceptable, stably dosed mood stabilizing medication regimen, including treatment regimens with atypical antipsychotic drugs, for \> 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for a list of medications not allowed for mood stabilization purposes. Exceptions to this may be made on a case-by-case basis following agreement by the Investigator and the Sponsor. Also, subjects with untreated BD1 can be enrolled if deemed adequately stable by the Investigator.

What they're measuring

To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.

Timeframe: From time zero to the end of the 24 hour 3-dose interval at steady state.

To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.

Timeframe: From time zero to the end of the 24 hour 3-dose interval at steady state.

To characterize AL001 lithium PK under the conditions of this study