Psychiatric DisordersPhase 1NCT06853171
Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
A Phase 1 study testing KarXT and KarX-EC in people with Psychiatric Disorders, run by Bristol-Myers Squibb at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- KarXT and KarX-EC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Apr 2025to 22 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Schizophrenia or schizoaffective disorder
- Bipolar I or II disorder
- Attention-deficit/hyperactivity disorder (ADHD)
- Tourette's disorder
- 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).
Who cannot join
- 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/exclusion criteria apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Local Institution - 0007
Decatur, Georgia, 30030
Local Institution - 0005
Little Rock, Arkansas, 72204
Local Institution - 0006
Orange, California, 92868
Local Institution - 0008
Overland Park, Kansas, 66212
About this study
Official title: An Open-label, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
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.
- Conditions
- Psychiatric Disorders
- Being tested
- KarXT, KarX-EC
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called Xanomeline and Trospium Chloride Capsule, BMS-986510
Specified dose on specified days
KarX-ECDrug
Also called Xanomeline Enteric-coated, BMS-986519
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: KarXT |
| Cohort 2 | Experimental | Not described Receives: Drug: KarXT; Drug: KarX-EC |
| Cohort 3 | Experimental | Not described Receives: Drug: KarXT; Drug: KarX-EC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Measured: Up to Day 43
Number of participants with Serioues AEs (SAEs)
Measured: Up to Day 43
Number of participants with AEs of Special Interest (AESIs)
Measured: Up to Day 43
Secondary outcomes (12)
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 15
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Up to Day 15
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 15
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 15
Concentration at the end of a dosing interval (Ctau)
Measured: Up to Day 15
Cmax accumulation index (AI_Cmax)
Ratio of maximum observed plasma concentration at steady-state on Day 5 to maximum observed plasma concentration after first dose
Measured: Up to Day 15
AUC accumulation index (AI_AUC)
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
Measured: Up to Day 15
Ctau accumulation index (AI_Ctau)
Ratio of concentration at the end of the dosing interval at steady-state on Day 5 to maximum observed plasma concentration after first dose
Measured: Up to Day 15
Average concentration within a dosing interval at steady-state (Css-avg)
Measured: Up to Day 15
Apparent total body clearance (CLT/F)
Measured: Up to Day 15
Effective elimination half-life during dosing interval (T-HALF(eff))
Measured: Up to Day 15
T-HALFeff based on AUC observed (T-HALFeff_AUC)
Effective elimination half-life based on degree of area under the plasma concentration-time curve accumulation observed
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start29 Apr 2025
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853171
- Sponsor's protocol ID
- CN012-0022
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT06853171
- Acronym / sponsor ID
- CN012-0022
- Conditions
- Psychiatric Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: KarXT |
| Cohort 2 | Experimental | Drug: KarXT, Drug: KarX-EC |
| Cohort 3 | Experimental | Drug: KarXT, Drug: KarX-EC |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KarXTAlso: Xanomeline and Trospium Chloride Capsule, BMS-986510Specified dose on specified days | Drug | Cohort 1, Cohort 2, Cohort 3 |
| KarX-ECAlso: Xanomeline Enteric-coated, BMS-986519Specified dose on specified days | Drug | Cohort 2, Cohort 3 |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 43
Number of participants with Serioues AEs (SAEs)
Time frame: Up to Day 43
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to Day 43
12 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 15
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 15
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 15
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 15
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to Day 15
Cmax accumulation index (AI_Cmax)
Time frame: Up to Day 15
AUC accumulation index (AI_AUC)
Time frame: Up to Day 15
Ctau accumulation index (AI_Ctau)
Time frame: Up to Day 15
Average concentration within a dosing interval at steady-state (Css-avg)
Time frame: Up to Day 15
Apparent total body clearance (CLT/F)
Time frame: Up to Day 15
Effective elimination half-life during dosing interval (T-HALF(eff))
Time frame: Up to Day 15
T-HALFeff based on AUC observed (T-HALFeff_AUC)
Time frame: Up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Related trials for Psychiatric Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KarXT and KarX-EC in people with Psychiatric Disorders, run by Bristol-Myers Squibb at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: Up to Day 43). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.