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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Local Institution - 0005Little Rock, AR
Local Institution - 0006Orange, CA
Local Institution - 0007Decatur, GA
Local Institution - 0008Overland Park, KS
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor