Study of AL001 for Bipolar I Disorder
This study is testing a new form of lithium, called AL001, in people with Bipolar I Disorder. Researchers want to see how AL001 compares to the commonly used lithium carbonate in terms of safety and how it moves through the brain and body. The main goal is to understand if AL001 can reach the brain effectively. This study is looking for 20 participants, aged 18 to 65. If successful, AL001 could offer a new treatment option. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 20 participants. It compares AL001 capsules to lithium carbonate capsules.
- What's involved
- You would take AL001 and lithium carbonate for 14 days each, staying overnight at MGH's research unit for two separate 2-week periods. This involves two 24-hour periods with multiple MRIs and blood draws.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured from time zero to the end of the 24-hour 3-dose interval at steady state.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- 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.
- 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.
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma Cmax ss = Maximum plasma concentration at steady-state.
- To characterize AL001 lithium PK under the conditions of this studyFrom time zero to the end of the 24 hour 3-dose interval at steady state.
Brain Cmax ss = Maximum brain concentration at steady-state
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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)
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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.
- To characterize AL001 lithium PK under the conditions of this studyFrom 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.
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom 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
- To characterize AL001 lithium PK under the conditions of this studyFrom time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma swing 24 h = \[(Cmax ss - Cmin ss)/ Cmin ss \]
- To characterize AL001 lithium PK under the conditions of this studyFrom time zero to the end of the 24 hour 3-dose interval at steady state.
Brain swing 24 h = \[(Cmax ss - Cmin ss)/ Cmin ss \]
- To characterize AL001 lithium PK under the conditions of this studyFrom time zero to the end of the 24 hour 3-dose interval at steady state.
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
- 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.From enrollment to end of follow-up period at Day 42(P2)
Proportion of participants with adverse events and serious adverse events
- 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.From enrollment to Day 23 (P2)
Proportion of participants with abnormal vital signs
- 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.From enrollment to Day 23 (P2)
Proportion of participants with abnormal values and change from baseline reading for each ECG parameter. Individual parameters including heart rate, PR, QT, QTcF, QRS, and RR intervals will be collected.
- 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.From enrollment to Day 23 (P2)
Proportion of participants with abnormal findings on physical exam.
- 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.From enrollment to Day 23 (P2)
Proportion of participants with abnormal values and changes from baseline for each Safety laboratory test (standard hematology, blood chemistry \[clinical chemistry\], urinalysis, and pregnancy test \[for females of childbearing potential only).
- 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.From enrollment to Day 23 (P2)
Proportion of participants with prevalence of plasma lithium concentrations above 1.2 mEq/L
- 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.From enrollment to Day 23 (P2)
Proportion of participants with prevalence of plasma salicylic acid concentrations above 30 mg/dL