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

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 and fewer side effects. If successful, this new form of lithium could offer a new and safe treatment option for psychiatric and neurological disorders.

This study involves two, 2-week long overnight stays at the main campus of Massachusetts General Hospital (MGH). During these stays, participants will receive lithium carbonate for one stay and the AL001 for the other. There are frequent blood draws and brain MRI scans during two periods of the study to look at how the AL001 is broken down in the body and to see how it reaches the brain. This study will compare AL001 to a study reference treatment of lithium carbonate. The majority of the blood draws and MRIs will occur over a 24 hour period during each 2-week long overnight stay at MGH.