Xanomeline/Trospium Chloride for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how the body processes a treatment called KarXT, a combination of xanomeline and trospium chloride, by focusing on different types of metabolism in healthy individuals. Researchers aim to determine how various genetic profiles affecting metabolism influence the treatment's processing. It is suitable for healthy individuals who know their specific metabolism type—normal, intermediate, poor, or very fast. Participants should be in good health and have a BMI between 18.0 and 32.0. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for specific guidance.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the treatment KarXT, which combines xanomeline and trospium chloride, is generally well tolerated. In studies involving people with schizophrenia, KarXT reduced symptoms of psychosis and was mostly safe. The most common side effects included mild stomach issues. However, some individuals might experience bladder difficulties, such as trouble emptying it. Risks may also exist for those with liver or kidney problems, and an increase in heart rate has been observed.
Overall, while KarXT has shown promise in previous studies, potential side effects should be considered when deciding to join a clinical trial.12345Why do researchers think this study treatment might be promising?
KarXT is unique because it combines two different active ingredients, xanomeline and trospium chloride, to target conditions like schizophrenia and Alzheimer's disease. Unlike standard treatments that primarily focus on dopamine pathways, KarXT also engages muscarinic receptors, which might lead to fewer side effects related to movement or weight gain. Researchers are excited about KarXT's potential to offer an alternative with a better side effect profile, providing a new approach for patients who might not respond well to current antipsychotics or Alzheimer's medications.
What evidence suggests that KarXT might be an effective treatment for healthy subjects?
Research has shown that KarXT, a combination of xanomeline and trospium chloride, may help treat schizophrenia. Studies have found it effective in reducing symptoms of acute psychosis, a serious mental condition where people lose touch with reality. KarXT outperformed placebos, with improvements appearing as soon as two weeks after starting treatment. These benefits mainly result from xanomeline's effect on specific brain receptors involved in signaling. Overall, current evidence suggests that KarXT could be a helpful treatment option for schizophrenia.56789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for healthy adults who can metabolize drugs normally, at an intermediate level, poorly, or very quickly. Specific genetic testing may be required to determine eligibility based on how their body processes certain medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KarXT to evaluate the pharmacokinetics of xanomeline in different CYP2D6 metabolizer phenotypes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KarXT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Karuna Therapeutics
Lead Sponsor