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Compares treatment options for Bipolar I Disorder
Official 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
ClinicalTrials.gov ID: NCT07540338
What this study is testing
What is AL001?
AL001 is an investigational medicine, being studied as a potential treatment for bipolar i disorder.
Also referred to as lithium salicylate/L-proline cocrystal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are: How safe is AL001 when compared to lithium carbonate?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people with Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by a DSM-5-TR...
- Assessment of subject's mental health status will be conducted to avoid enrolling people who are on the verge of a manic or depressive episode...
- Clinically acceptable, stably dosed mood stabilizing medication regimen, including treatment regimens with atypical antipsychotic drugs, for \> 30...
- Able to understand and follow instructions during the study as determined by the Investigator.
- Willing to follow study procedures.
You likely can't join if
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings (including prolonged QT...
- Any history of drug hypersensitivity or asthma (with the exception of childhood asthma), urticaria or other severe allergic diathesis.
- Presence or history of any disorder other than the diagnosis under study that may prevent the successful completion of the study.
- Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the...
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- History or presence of gastrointestinal disease including chronic gastritis, peptic ulcers, inflammatory bowel disease, hemorrhagic gastritis, or...
See the full eligibility criteria
Who can join
- people with Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by a DSM-5-TR BD1 diagnosis and the Investigator's review of medical and surgical...
- Assessment of subject's mental health status will be conducted to avoid enrolling people who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of...
- Clinically acceptable, stably dosed mood stabilizing medication regimen, including treatment regimens with atypical antipsychotic drugs, for \> 30 days prior to Screening visit, with no medication changes planned over...
- Able to understand and follow instructions during the study as determined by the Investigator.
- Willing to follow study procedures.
- Willing and able to adhere to study restrictions and to be confined at the clinical research center per protocol requirements.
- Any gender, race, or ethnicity.
- Able to understand and provide written informed consent.
- Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until after Treatment Period 2 in-clinic follow-up visit on Day 23 (P2).
- Females must meet one of the following criteria: Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
- Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after the last dose of the study drug on Day 14 (P2).
- One of the following highly-effective contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after the last dose of the study drug on Day 14 (P2).
- i. Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, or transdermal patch).
- ii. Intrauterine device (with or without hormones)
- iii. Male partner vasectomized at least 6 months prior to the Screening visit.
- One of the following double-barrier contraceptive methods, used from the Screening visit through to at least 30 days after the last dose of the second study drug on Day 14 (P2):
- i. Male condom used simultaneously with diaphragm plus spermicide.
- ii. Male condom used simultaneously with cervical cap plus spermicide. Or Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal...
- Able to communicate in English, including speaking, reading, and writing.
- Body mass index (BMI) within 18.0 to 31.0 kg/m2, inclusive, and body weight of at least 50 kg at the time of Screening.
- ECG recording, after at least 5 minutes of rest in a supine position, without clinically significant abnormalities as determined by the Investigator.
What rules you out
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings (including prolonged QT interval), or clinical laboratory findings (as determined by the...
- Any history of drug hypersensitivity or asthma (with the exception of childhood asthma), urticaria or other severe allergic diathesis.
- Presence or history of any disorder other than the diagnosis under study that may prevent the successful completion of the study.
- Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product...
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- History or presence of gastrointestinal disease including chronic gastritis, peptic ulcers, inflammatory bowel disease, hemorrhagic gastritis, or duodenitis.
- History or presence of acute or chronic liver disease as determined by the Investigator.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study treatments.
- Any history of frequent headache or migraine.
- Kidney disease (eGFR \< 60 mL/minute/1.73 m2).
- Uncontrolled tachy/brady arrhythmias, atrial fibrillation, or coronary heart failure.
- Systemic related exclusions:
- Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy.
- Positive test results for HIV, HBV, or HCV (unless quantitative PCR negative for HCV) at Screening.
- Severe hepatic impairment (Child-Pugh Class C).
- Uncontrolled hypertension with a sustained blood pressure \> 160/100 mmHg at Screening, or at check-in on Day -1 (P1).
- Fever (body temperature \> 101.4°F [38.5°C]), acute upper respiratory, or any other infections at Screening, or at check-in on Day -1 (P1).
- Psychiatric or neurological illnesses other than-and not associated with-bipolar I disorder (e.g., bipolar II disorder exclusively, schizophrenia or other psychotic syndromes, Parkinson's disease and related movement...
- Treatment with haloperidol, antipsychotics (except stable regimens), monoamine oxidase inhibitors, neuromuscular blocking agents. people who have ever received chronic immunosuppressant treatment (excluding topical or...
- Current and during lithium treatment hyponatremia, defined as serum sodium laboratory value outside the standard reference range.
- The regular and long-term use of any medication, supplement, or OTC medication within 14 days prior to the Screening visit or at least 6 times the respective elimination half-life, whichever is longer, through the...
- Hormonal contraceptives for females of childbearing potential.
- Acetaminophen (up to 1000 mg TID) at the discretion of the Investigator.
- Low-Dose aspirin for cardio protection.
- Non-medicated ophthalmic products (for lubrication and comfort).
- Clinically acceptable, stably dosed mood stabilizing medication regimen for \> 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for list of medications...
- PRN medications needed for treatment of AE's during the study at the joint discretion of the Investigator and the Sponsor, reviewed on a case-by-case basis.
- people treated with electroconvulsive therapy within 6 months prior to Screening visit.
- Unwilling to refrain from consumption of poppy seeds or quinine (tonic water) 48 hours prior to check-in on Day -1 (P1) and throughout the course of the study.
- Aspirin/nasal polyposis/asthma syndrome.
- Female who is breastfeeding.
- Female who is pregnant according to the pregnancy test at Screening or on Day -1 (P1); female planning to become pregnant during the study.
- History of adverse or hypersensitivity reaction to lithium, aspirin, salicylate, L-proline, or any investigational or reference article excipient.
- Drug/alcohol abuse:
- History of drug abuse (barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis) within the last 12 months or a positive urine drug screen at Screening or Day -1 (P1).
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements or positive ethanol (alcohol) test at Screening or Day -1 (P1).
- More than moderate current alcohol consumption. people will be advised to consume no more than 2 units of alcohol per day and completely abstain from 72 hours prior to any study visit (1 unit is equal to approximately...
- Demonstrating excess xanthine consumption (e.g., ingests more than 5 cups of coffee or equivalent per day). Also, subject is not willing to refrain from xanthine products for 48 hours prior to check-in on Day -1 (P1)...
- Participation in a clinical trial and receipt of an investigational medication within 30 days or 5 half-lives (if known), whichever is greater, prior to the first dose of the current study drug.
- History of untreated thyroid dysfunction (due to potential lithium drug-disease interaction).
- Screening MRI-related exclusion criteria: intracranial mass, evidence of other anatomical findings that might affect safety or causes of cognitive/behavioral impairment as assessed by a qualified neurologist. people...
- people with any past apparent suicide attempt or suicidal behavior, including those with a lifetime history of suicide attempt(s) or a past year level 4 or higher SI/B (C-SSRS) or past month SI/B (C-SSRS) of any kind.
- Suspected of having or at risk for Brugada Syndrome.
- Central nervous system-related exclusions: Any medical condition that in the Investigator's judgement could affect subject safety and scientific integrity of the study, e.g., untreated hypothyroidism (TSH \>10 mIU/L) or...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.