Psychiatric Disorders
Conditions
Brief summary
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.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* LAR (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines. * Confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) psychiatric diagnosis of 1 of the following: 1. Schizophrenia or schizoaffective disorder 2. Bipolar I or II disorder 3. Attention-deficit/hyperactivity disorder (ADHD) 4. Tourette's disorder 5. Autism spectrum disorder (ASD) * Participant is judged by the investigator to be clinically stable (eg, no psychiatric hospitalization within the last 6 months; no imminent risk of suicide or injury to self, others, or property).
Exclusion criteria
* Any clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, GI (including active obstructive GI disorders), carcinoma, active biliary disorders (eg, symptomatic gallstones) and/or urological disorder, congestive heart failure (uncontrolled), or CNS infection that would pose a risk to the participants if they were to participate in the study or that might confound the results of the study. * Participant has a risk for suicidal behavior during the study, as determined by the investigator's clinical judgment and C-SSRS. * eGFR \< 60 mL/min. * History of Gilbert's Disease or history of liver disease (Child-Pugh class A and higher). * History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma. * Participants with history of bladder stones or recurrent UTIs. * Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events (AEs) | Up to Day 43 |
| Number of participants with Serioues AEs (SAEs) | Up to Day 43 |
| Number of participants with AEs of Special Interest (AESIs) | Up to Day 43 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 15 | — |
| Concentration at the end of a dosing interval (Ctau) | Up to Day 15 | — |
| Cmax accumulation index (AI_Cmax) | Up to Day 15 | Ratio of maximum observed plasma concentration at steady-state on Day 5 to maximum observed plasma concentration after first dose |
| AUC accumulation index (AI_AUC) | Up to Day 15 | Ratio of area under the concentration-time curve in 1 dosing interval at steady-state on Day 5 to area under the concentration-time curve in 1 dosing interval after first dose |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 15 | — |
| Average concentration within a dosing interval at steady-state (Css-avg) | Up to Day 15 | — |
| Apparent total body clearance (CLT/F) | Up to Day 15 | — |
| Effective elimination half-life during dosing interval (T-HALF(eff)) | Up to Day 15 | — |
| T-HALFeff based on AUC observed (T-HALFeff_AUC) | Up to Day 15 | Effective elimination half-life based on degree of area under the plasma concentration-time curve accumulation observed |
| Ctau accumulation index (AI_Ctau) | Up to Day 15 | Ratio of concentration at the end of the dosing interval at steady-state on Day 5 to maximum observed plasma concentration after first dose |
| Maximum observed plasma concentration (Cmax) | Up to Day 15 | — |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 15 | — |
Countries
United States
Outcome results
None listed