Healthy VolunteersPhase 1NCT07063342
A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses
A Phase 1 study testing Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule and Trospium Chloride in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule and Trospium Chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jun 2025to 29 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
United Kingdom1 site, 1 recruiting
- Recruiting
Quotient Sciences
Nottingham, Nottinghamshire, NG1 6JS
Philip Evans, Site 0001, 4401159749000
About this study
Official title: Phase 1, 4-Part, Open-label (Parts 1 to 3) and Double-blind (Part 4) Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants, and to Evaluate Alternative Formulations of KarX (BMS-986519) and KarXT (BMS-986510) Following Single and Multiple Ascending Doses in Healthy Adult Participants
The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Trospium Chloride, Xanomeline MR, Xanomeline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline/Trospium Chloride CapsuleDrug
Also called BMS-986510, KarXT
Specified dose on specified days
Xanomeline Enteric CapsuleDrug
Also called BMS-986519, KarX-EC
Specified dose on specified days
Trospium ChlorideDrug
Also called BMS-986520, KarT
Specified dose on specified days
Xanomeline MRDrug
Also called BMS-986519, KarX-MR
Specified dose on specified days
XanomelineDrug
Also called BMS-986519, KarX
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule; Drug: Trospium Chloride |
| Part 2 | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule; Drug: Xanomeline MR |
| Part 3a | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule |
| Part 3b | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule; Drug: Xanomeline MR |
| Part 4a | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline; Drug: Placebo |
| Part 4b | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to Day 23
Time of maximum observed concentration (Tmax)
Measured: Up to Day 23
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 23
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 23
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Up to Day 23
Concentration at the end of a dosing interval (Ctau)
Measured: Up to Day 23
Apparent total body clearance (CLT/F)
Measured: Up to Day 23
Effective elimination half-life during dosing interval (T-HALF(eff))
Measured: Up to Day 23
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Measured: Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Measured: Up to 30 days after final dose of study intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 14
Secondary outcomes (22)
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Measured: Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Measured: Up to 30 days after final dose of study intervention
Number of participants with vital signs abnormalities
Measured: Up to 30 days after final dose of study intervention
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 30 days after final dose of study intervention
Number of participants with physical examination abnormalities
Measured: Up to 30 days after final dose of study intervention
Number of participants with clinical laboratory abnormalities
Measured: Up to 30 days after final dose of study intervention
Geometric mean ratio of Cmax
Measured: Up to Day 12
Geometric mean ratio of AUC(0-T)
Measured: Up to Day 12
Geometric mean ratio of AUC(INF)
Measured: Up to Day 12
Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Up to Day 12
Maximum observed concentration (Cmax)
Measured: Up to Day 16
Time of maximum observed concentration (Tmax)
Measured: Up to Day 16
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 16
Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12))
Measured: Up to Day 4
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 23
Apparent total body clearance (CLT/F)
Measured: Up to Day 16
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Up to Day 16
Effective elimination half-life during dosing interval (T-HALF(eff))
Measured: Up to Day 16
Cmax Accumulation Index: Ratio of Cmax at steady state to Cmax after first dose (AI_Cmax)
Measured: Up to Day 16
AUC(TAU) Accumulation Index: Ratio of AUC(TAU) at steady state to AUC(TAU) after first dose (AI_AUC)
Measured: Up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start27 Jun 2025
- Primary completion29 Mar 2027 (estimated)
- Study completion29 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 236 participants (estimated)
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
- NCT07063342
- Sponsor's protocol ID
- CN012-0043
- Other IDs
- U1111-1321-3511, IRAS1011809
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, 4-Part, Open-label (Parts 1 to 3) and Double-blind (Part 4) Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants, and to Evaluate Alternative Formulations of KarX (BMS-986519) and KarXT (BMS-986510) Following Single and Multiple Ascending Doses in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07063342
- Acronym / sponsor ID
- CN012-0043
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 29 Mar 2027 (estimated)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 14 Jul 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.
The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Xanomeline/Trospium Chloride Capsule, Drug: Xanomeline Enteric Capsule, Drug: Trospium Chloride |
| Part 2 | Experimental | Drug: Xanomeline/Trospium Chloride Capsule, Drug: Xanomeline Enteric Capsule, Drug: Xanomeline MR |
| Part 3a | Experimental | Drug: Xanomeline/Trospium Chloride Capsule, Drug: Xanomeline Enteric Capsule |
| Part 3b | Experimental | Drug: Xanomeline/Trospium Chloride Capsule, Drug: Xanomeline Enteric Capsule, Drug: Xanomeline MR |
| Part 4a | Experimental | Drug: Xanomeline/Trospium Chloride Capsule, Drug: Xanomeline, Drug: Placebo |
| Part 4b | Experimental | Drug: Xanomeline/Trospium Chloride Capsule, Drug: Xanomeline, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Xanomeline/Trospium Chloride CapsuleAlso: BMS-986510, KarXTSpecified dose on specified days | Drug | Part 1, Part 2, Part 3a, Part 3b, Part 4a, Part 4b |
| Xanomeline Enteric CapsuleAlso: BMS-986519, KarX-ECSpecified dose on specified days | Drug | Part 1, Part 2, Part 3a, Part 3b |
| Trospium ChlorideAlso: BMS-986520, KarTSpecified dose on specified days | Drug | Part 1 |
| Xanomeline MRAlso: BMS-986519, KarX-MRSpecified dose on specified days | Drug | Part 2, Part 3b |
| XanomelineAlso: BMS-986519, KarXSpecified dose on specified days | Drug | Part 4a, Part 4b |
| PlaceboSpecified dose on specified days | Drug | Part 4a, Part 4b |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to Day 23
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 23
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 23
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 23
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 23
Concentration at the end of a dosing interval (Ctau)
Time frame: Up to Day 23
Apparent total body clearance (CLT/F)
Time frame: Up to Day 23
Effective elimination half-life during dosing interval (T-HALF(eff))
Time frame: Up to Day 23
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Time frame: Up to 30 days after final dose of study intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 14
22 secondary outcomes
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
Time frame: Up to 30 days after final dose of study intervention
Number of participants with vital signs abnormalities
Time frame: Up to 30 days after final dose of study intervention
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 30 days after final dose of study intervention
Number of participants with physical examination abnormalities
Time frame: Up to 30 days after final dose of study intervention
Number of participants with clinical laboratory abnormalities
Time frame: Up to 30 days after final dose of study intervention
Geometric mean ratio of Cmax
Time frame: Up to Day 12
Geometric mean ratio of AUC(0-T)
Time frame: Up to Day 12
Geometric mean ratio of AUC(INF)
Time frame: Up to Day 12
Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 12
Maximum observed concentration (Cmax)
Time frame: Up to Day 16
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 16
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 16
Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12))
Time frame: Up to Day 4
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 23
Apparent total body clearance (CLT/F)
Time frame: Up to Day 16
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to Day 16
Effective elimination half-life during dosing interval (T-HALF(eff))
Time frame: Up to Day 16
Cmax Accumulation Index: Ratio of Cmax at steady state to Cmax after first dose (AI_Cmax)
Time frame: Up to Day 16
AUC(TAU) Accumulation Index: Ratio of AUC(TAU) at steady state to AUC(TAU) after first dose (AI_AUC)
Time frame: Up to Day 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- BMS Clinical Trial InformationLink 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 Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule and Trospium Chloride in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 2 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) (time frame: Up to Day 23). The study lists 13 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 17 Aug 2026.