KarXT for Healthy Subjects

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

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Karuna Therapeutics

Disqualifiers: Cardiovascular, Pulmonary, Renal, Gastrointestinal, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the medication KarXT is processed in breast milk and blood. It targets healthy women who are breastfeeding. Participants must be at least four weeks postpartum, able to consistently produce breast milk, and willing to pump milk exclusively during the study. The research aims to ensure the safety and effectiveness of KarXT for breastfeeding mothers. As a Phase 4 trial, KarXT has already received FDA approval and proven effective, and this research helps to understand its benefits for more patients.

What is the safety track record for this treatment?

Research has shown that KarXT, a treatment combining xanomeline and trospium, has generally been well tolerated in studies focusing on adults with schizophrenia. Reported side effects relate to the drug's interaction with certain brain receptors, suggesting these effects are predictable and manageable.

KarXT has undergone several trials, consistently demonstrating a safety profile that aligns with expectations. Although specific data on the new trial isn't available yet, its previous use in other conditions provides a reasonable indication of its safety for healthy individuals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for mental health conditions like schizophrenia target neurotransmitters such as dopamine. But KarXT works differently, targeting muscarinic receptors in the brain. This novel mechanism may offer improvements in treating symptoms like hallucinations and cognitive issues without causing the typical side effects associated with current antipsychotics, such as weight gain or sedation. Researchers are excited about KarXT because it represents a fresh approach that could lead to better outcomes for patients.

What is the effectiveness track record for KarXT?

Research has shown that KarXT, a combination of xanomeline and trospium, is a promising treatment for schizophrenia. Studies have found that it can improve symptoms in people with this condition. Additionally, KarXT may cause less weight gain, potentially reducing the risk of metabolic issues like diabetes. Notably, KarXT is already approved for treating schizophrenia, as this trial is in Phase 4. Overall, evidence supports KarXT as an effective option for managing schizophrenia. ^{4 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 lactating women who are currently breastfeeding. The study aims to understand how a drug called KarXT, which they will take orally, behaves in their body and breast milk.

Inclusion Criteria

My BMI is between 18 and 35, and I weigh at least 50 kg.

Participants should have well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study

Participants should be willing to exclusively pump breast milk throughout the treatment period and during the 24-hour post last dose period of milk collection during the CRU domicile period

Exclusion Criteria

My organs function properly, and my medical tests are within normal ranges.

I do not have any major health issues that could affect my safety or the study results.

Other protocol defined inclusion/exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple oral administrations of KarXT to evaluate PK in breast milk and plasma

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KarXT

Trial Overview The focus of the trial is on KarXT, a combination of xanomeline and trospium chloride. It's being given to see how much of it passes into breast milk and blood plasma after multiple doses.

How Is the Trial Designed?

Group I: KarXT Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Karuna Therapeutics

Lead Sponsor

Trials

17

Recruited

4,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9681874/

Effectiveness of KarXT (xanomeline-trospium) for cognitive ... These findings suggest that KarXT may have a separable and meaningful impact on cognition, particularly among patients with cognitive impairment.

2. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.6.624

KarXT for schizophrenia–effectiveness and value KarXT (Karuna Therapeutics) is an emerging treatment for schizophrenia, with a regulatory decision anticipated in September 2024.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04659161

NCT04659161 | A Study to Assess Efficacy and Safety of ... The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) ...

4. 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.

5. icer.org icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-treatment-for-schizophrenia/

ICER Publishes Evidence Report on Treatment for ... KarXT was associated with significantly lower weight gain, which may translate into fewer cases of metabolic syndrome, diabetes, and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03697252

NCT03697252 | A Study to Assess Safety and Efficacy of ... The secondary objectives of the study are to assess overall safety and tolerability of KarXT in adult inpatients with a DSM-5 diagnosis of schizophrenia.

7. 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.

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

216158Orig1s000 - accessdata.fda.gov ... KarXT1) for the treatment of schizophrenia in adults. Cobenfy is a fixed-combination product containing two small molecules, xanomeline ...

9. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)02190-6/abstract

Efficacy and safety of the muscarinic receptor agonist ... The EMERGENT-2 trial aimed to assess the efficacy and safety of KarXT in people with schizophrenia experiencing acute psychosis.