Trial · NCT07540338
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| 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) |
| 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 tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours |
| 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 tmin ss = Time to reach the minimum brain concentration at steady-state over 24 hours |
| 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/Plasma AUCtau ss ratio = Ratio of brain/plasma areas 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/Plasma Cmax ss ratio = Ratio of brain/plasma minimum concentrations 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/Plasma Cmin ss ratio = Ratio of brain/plasma minimum concentrations 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 apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss |
| 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. | Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours |
| 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. | Average brain concentration at steady-state (Css ave brain) = Brain 24 h AUCtau ss/24 hours |
| 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 degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma |
| 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 degree of fluctuation at steady-state (FIbrain ss) = Ratio of brain 24 h (Cmax ss - Cmin ss) to Css ave brain |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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