A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability 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
Alzamend Neuro, Inc.
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.
Description
This study is researching the effects of a new type of crystallized lithium, AL001, on it's ability to reach the brain and have an effect in subjects with bipolar I disorder diagnosis. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the AL001 can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with AL001 when compared to commonly used lithium. This past research suggests that AL001 may be more effective, potentially allowing for lower doses a…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. 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…
Interventions
- DrugAL001
Crystallized lithium
- DrugLithium carbonate
Lithium carbonate
Location
- Massachusetts General HospitalBoston, Massachusetts