Skip to content
DataLookout
Start free
Menu

NCT07540338

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

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

See at-risk trials from Alzamend Neuro, Inc.

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Jul 2027 Show 6 more changesShow less
    • Eligibility criteria expanded, about 65 words
    • Primary endpoints: details revised at 2 of 30 entries
    • Enrollment closed, study ongoing
    • Study completion pushed from Dec 2026 to Dec 2027
    • Secondary endpoints: details revised at 4 of 11 entries
    • Site details revised
  2. Eligibility criteria expanded, about 79 words
    • Start date changed from estimate of Apr 2026 to May 11, 2026
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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
Timeframe: 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.
Timeframe: From enrollment to end of follow-up period at Day 42(P2)

Secondary (2)

To characterize AL001 salicylic acid PK under the conditions of this study
Exploring Brain Pharmacodynamics using Magnetic Resonance Spectroscopy

Arms and interventions

Sequence 1: AL001 then lithium carbonateOther

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 AL001Other

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.

Drugs: AL001, Lithium carbonate

Sites

1 site in 1 country

  • Massachusetts General HospitalBoston, Massachusetts, United States