KarXT for Drug Interaction Study

Recruiting at 1 trial location

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Karuna Therapeutics

Disqualifiers: Organ dysfunction, Cirrhosis, GI disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 24 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a new treatment, KarXT, interacts with three common drugs: midazolam, fexofenadine, and digoxin. Researchers aim to determine if KarXT alters the levels of these drugs in the body. The trial seeks healthy adults without major health issues, particularly those related to the heart, liver, or digestion. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that KarXT is likely to be safe for humans?

Research has shown that KarXT, a combination of xanomeline and trospium, is generally well tolerated by patients. Studies have found that the side effects are typical for these types of drugs. Common side effects include dry mouth and constipation, but these are usually mild.

KarXT has been tested in people with schizophrenia, and the results indicated it was as safe as a placebo (a harmless pill that does nothing). This suggests that KarXT is quite safe for humans.

Although this trial is in the early stages, safety information from other studies provides a good indication of how well people tolerate it. This should help prospective participants feel more confident about its safety when considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

KarXT is unique because it targets both muscarinic and nicotinic receptors in the brain, which is different from most current treatments for psychiatric conditions that primarily focus on dopamine and serotonin systems. This dual-action mechanism could potentially offer improved symptom management with fewer side effects. Researchers are excited about KarXT because it opens up new possibilities for treating conditions like schizophrenia with a fresh approach, potentially addressing unmet needs and providing relief for patients who don't respond well to existing medications.

What evidence suggests that KarXT could be effective in this drug interaction study?

Research has shown that KarXT, a combination of xanomeline and trospium chloride, helps treat schizophrenia. Studies have found that it improves both the negative and positive symptoms experienced by people with schizophrenia. KarXT has a manageable safety profile, meaning it causes few unwanted side effects. Early results also suggest it does not lead to significant weight gain, a common issue with other treatments. Overall, KarXT appears promising for treating schizophrenia symptoms. ^{3 6 7 8 9}

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 with a Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, without any significant medical history, abnormal physical exams, ECGs, vital signs or lab results that would suggest health issues.

Inclusion Criteria

I am healthy with normal medical exams and tests.

My BMI is between 18.0 and 32.0.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive KarXT and are monitored for drug level effects on midazolam, fexofenadine, and digoxin

Up to approximately 24 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 23 days

What Are the Treatments Tested in This Trial?

Interventions

• KarXT

Trial Overview The study is testing how KarXT affects the levels of three other drugs in the body: Midazolam (a sedative), Fexofenadine (an antihistamine), and Digoxin (used to treat heart conditions).

How Is the Trial Designed?

Group I: Part 3 Experimental Treatment 2 Interventions

Group II: Part 2 Experimental Treatment 2 Interventions

Group III: Part 1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Karuna Therapeutics

Lead Sponsor

Trials

17

Recruited

4,100+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920996424004328

A network meta-analysis of KarXT and commonly used ... KarXT and commonly used antipsychotics were more efficacious than placebo at reducing symptoms, but there were no clear differences in short-term efficacy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11144989/

KarXT for schizophrenia–effectiveness and value Initial data from acute settings suggest that weight gain may not be an important side effect of KarXT, but longer-term data are needed to confirm this.

3. nature.com nature.com/articles/s41537-024-00525-6

Efficacy of xanomeline and trospium chloride in ... Xanomeline and trospium chloride (formerly known as KarXT) significantly improved symptoms of schizophrenia and was generally well tolerated.

4. academic.oup.com academic.oup.com/ijnp/advance-article/doi/10.1093/ijnp/pyaf045/8190028

Efficacy and Safety of the Muscarinic Receptor Agonist KarXT ... KarXT offers significant improvements in both negative and positive symptoms of schizophrenia with a manageable safety profile. Its potential as ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2818047

Efficacy and Safety of Xanomeline-Trospium Chloride in ... This randomized clinical trial evaluates the efficacy and safety of xanomeline-trospium chloride vs placebo in adults with schizophrenia.

6. nature.com nature.com/articles/s41537-022-00320-1

Safety and tolerability of KarXT (xanomeline–trospium) in a ... KarXT was generally well tolerated with an AE profile consistent with the activity of xanomeline–trospium at muscarinic receptors.

7. cobenfyhcp.com cobenfyhcp.com/safety

Cobenfy™ (xanomeline and trospium chloride) Safety Data COBENFY is contraindicated in patients with: urinary retention; moderate or severe (Child-Pugh Class B or C) hepatic impairment; gastric retention; history of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04659161

NCT04659161 | A Study to Assess Efficacy and Safety of ... This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/216158Orig1s000IntegratedR.pdf

216158Orig1s000 - accessdata.fda.gov ... combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist. Other product name(s). KarXT. Applicant.