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
← catalyst calendarNCT07540338 · readout ≤ 134 d
Sponsored by Alzamend Neuro, Inc. (industry) · ALZN — their whole pipeline →. With Massachusetts General Hospital.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
20estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-11 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2026-04-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Bipolar I Disorder
Interventions
- Drug: AL001 — also filed as lithium salicylate/L-proline cocrystal
- Drug: Lithium carbonate
Primary outcomes
what the primary-completion date above is the date OFTo evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
measured 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.
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured 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
measured From time zero to the end of the 24 hour 3-dose interval at steady state.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to end of follow-up period at Day 42(P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
measured From enrollment to Day 23 (P2)
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