Trial · 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
NCT07540338, Phase 1, Phase 2, Active not recruiting, Alzamend Neuro, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07540338. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07540338
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07540338
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Alzamend Neuro, Inc.
- Conditions
- Bipolar I Disorder
- Interventions
- AL001, Lithium carbonate
- First posted
- 2026-04-20
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | From time zero to the end of the 24 hour 3-dose interval at steady state. | Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters. |
| 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. | From time zero to the end of the 24 hour 3-dose interval at steady state. | Area under the plasma and brain concentration versus time curve (AUC) will be measured. |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state | Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Brain AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3- dose interval at steady-state |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Plasma Cmax ss = Maximum plasma concentration at steady-state. |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Brain Cmax ss = Maximum brain concentration at steady-state |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Brain tmax ss = Time to reach the maximum brain concentration at steady-state |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough |
| Primary | To characterize AL001 lithium PK under the conditions of this study | From time zero to the end of the 24 hour 3-dose interval at steady state. | Brain Cmin ss = Minimum brain concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough) |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07540338
GET https://conductscience.org/api/trials/v1/NCT07540338/registered?page=2