AL001 for Pharmacokinetics
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new form of lithium, AL001, to evaluate its safety and effectiveness compared to the more common Lithium Carbonate. Researchers aim to understand how the body and brain absorb and process AL001. Participants will take both medications during the trial and undergo MRIs and blood draws. The study seeks healthy individuals without a history of serious medical or psychiatric conditions who can commit to staying overnight at the research facility during the trial periods. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications, including over-the-counter drugs, vitamins, and herbal supplements, at least 14 days before the study begins and throughout the study period. However, hormonal contraceptives and acetaminophen (up to 1000 mg per day) are allowed.
Is there any evidence suggesting that AL001 is likely to be safe for humans?
Research has shown that AL001, a new form of lithium, was well tolerated in earlier studies. These studies indicate that AL001 is safe and does not cause serious side effects.
Lithium Carbonate, already used to treat mood disorders, has a long history. Some animal studies have shown negative effects on male reproductive organs, but this has not been a major concern in humans.
Overall, earlier research has found both AL001 and Lithium Carbonate to be safe. Participants might experience some side effects, but these are usually not serious.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AL001 because it offers a new approach to mood stabilization, potentially setting it apart from traditional treatments like lithium carbonate. Unlike lithium, which has been a standard treatment for bipolar disorder and works by influencing neurotransmitter activity, AL001 may target mood regulation through a different mechanism, possibly involving novel pathways or receptors. This could mean more effective management of symptoms with possibly fewer side effects. Additionally, if AL001 demonstrates quicker or more sustained effectiveness, it could significantly improve quality of life for those living with mood disorders.
What evidence suggests that AL001 might be an effective treatment compared to Lithium Carbonate?
This trial will compare the pharmacokinetics of AL001 and Lithium Carbonate. Research has shown that AL001, a new type of lithium, might be better absorbed by the brain while maintaining lower blood levels compared to traditional lithium. This could enhance effectiveness and reduce side effects. Early results from a small group of patients suggest that AL001 can slow disease progression by 48% over a year in certain conditions.
Participants may also receive Lithium Carbonate, a well-known treatment that typically takes 1 to 3 weeks to become effective. It has long been used to manage mood disorders. Experts agree that it reliably helps manage symptoms of conditions like bipolar disorder.12678Are You a Good Fit for This Trial?
Healthy adults aged 18-65, with a BMI of 18.0 to 30.0 kg/m2 and weight at least 50 kg, can join this trial. They must be in good health as confirmed by medical checks, understand English, and agree to use contraception if necessary. People with significant health issues or conditions that could affect the study's outcome cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either AL001 or Lithium Carbonate for 14 days, including overnight stays and multiple MRIs and blood draws
Washout
Participants undergo a washout period between treatment sequences
Treatment Period 2
Participants receive the alternate treatment (AL001 or Lithium Carbonate) for 14 days, including overnight stays and multiple MRIs and blood draws
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AL001
- Lithium Carbonate Capsule
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alzamend Neuro, Inc.
Lead Sponsor
Massachusetts General Hospital
Collaborator