KarXT for Mental Disorders

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.

Eligibility Criteria

This trial is for adolescents with psychiatric disorders. Participants must meet specific health criteria and have a diagnosis related to the study's focus on mental illness or problem behavior.

Inclusion Criteria

I have been diagnosed with a psychiatric condition like schizophrenia, bipolar disorder, ADHD, Tourette's, or autism.

Exclusion Criteria

I have a history of Gilbert's Disease or liver disease.

I have had bladder stones or frequent UTIs.

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

My kidney function is reduced.

I have or am at high risk for urinary, gastric retention, or glaucoma.

Participant Groups

The trial is testing KarXT, which combines xanomeline and trospium chloride in different doses and ratios, to see how safe it is, how well it's tolerated by patients, and how their bodies process it.

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

Group II: Cohort 2Experimental Treatment2 Interventions

Group III: Cohort 1Experimental Treatment1 Intervention