Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06921590 | 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 Healthy Adult Subjects | PHASE1 | ACTIVE NOT_RECRUITING | 6 | — | — | May 9, 2025 | Dec 1, 2025 | Dec 9, 2025 | 1 | United States |
• Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters Area under the plasma and brain concentration versus time curves (AUC) will be measured.
Proportion of participants with adverse events and serious adverse events
| Arm | Type | Description |
|---|---|---|
| Sequence 1: AL001 then Lithium Carbonate | OTHER | Participants take 1050 mg of AL001 TID for 14 days then after a washout period, take 150 mg TID of Lithium Carbonate for 14 days. |
| Sequence 2: Lithium Carbonate then AL001 | OTHER | Participants take 150 mg of Lithium Carbonate TID for 14 days, then after a washout period, take 1050 mg of AL001 TID for 14 days. |
| Name | Type | Description |
|---|---|---|
| AL001 | DRUG | Crystalized Lithium |
| Lithium Carbonate Capsule | DRUG | Lithium Carbonate |
Inclusion Criteria: 1. Healthy subjects ≥18 and \<65 years old in reasonably good physical and psychological health as determined by the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laborator...