Healthy VolunteersPhase 1NCT06729970
A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
A Phase 1 study testing Xanomeline/Trospium Chloride, Lithium and Valproic Acid in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Xanomeline/Trospium Chloride, Lithium and Valproic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2024to 23 Jan 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female [individual not of childbearing potential (INOCBP)] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations.
- BMI of 18.0 to 32.0 kg/m2, inclusive.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded.
- Parts B and D only: History of pancreatitis.
- Any significant acute or chronic medical illness, in the opinion of the investigator.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
- Parts E \& F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Los Alamitos, California, 90720-3115
About this study
Official title: A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- Xanomeline/Trospium Chloride, Lithium, Valproic Acid, Lamotrigine
- Keywords
- KarXT, Lithium, Valproic acid, Drug-Drug Interaction study, Healthy Volunteers, BMS-986510, Pharmacokinetics, Lamotrigine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline/Trospium ChlorideDrug
Also called BMS-986510, KarXT
Specified dose on specified days
LithiumDrug
Specified dose on specified days
Valproic AcidDrug
Specified dose on specified days
LamotrigineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride; Drug: Lithium |
| Part B | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride; Drug: Valproic Acid |
| Part C | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride; Drug: Lithium |
| Part D | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride; Drug: Valproic Acid |
| Part E | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride; Drug: Lamotrigine |
| Part F | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride; Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to day 54
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to day 54
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to day 54
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to 28 days post discontinuation of dosing
Number of participants with serious adverse events (SAEs)
Measured: Up to 28 days post discontinuation of dosing
Number of participants with physical examination abnormalities
Measured: Up to 2 days post discontinuation of dosing
Number of participants with vital sign abnormalities
Measured: Up to 2 days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Measured: Up to 2 days post discontinuation of dosing
Number of participants with clinical laboratory abnormalities
Measured: Up to 2 days post discontinuation of dosing
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 2 days post discontinuation of dosing
Number of participants with AEs of Special Interest (AESIs)
Measured: Up to 28 days post discontinuation of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start26 Dec 2024
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel A \& B cohorts, then Parallel C \& D cohorts and then parallel E\&F cohorts
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- 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
- NCT06729970
- Sponsor's protocol ID
- CN012-0035
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2024
- Last updated
- 24 Feb 2026
- 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 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 6-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Single-dose Pharmacokinetics of KarXT and Effects of KarXT on the Single-dose Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
- ClinicalTrials.gov ID
- NCT06729970
- Acronym / sponsor ID
- CN012-0035
- Conditions
- Healthy Volunteers
- Keywords
- KarXT, Lithium, Valproic acid, Drug-Drug Interaction study, Healthy Volunteers, BMS-986510, Pharmacokinetics, Lamotrigine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 12 Dec 2024 (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 the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Parallel A \& B cohorts, then Parallel C \& D cohorts and then parallel E\&F cohorts
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Xanomeline/Trospium Chloride, Drug: Lithium |
| Part B | Experimental | Drug: Xanomeline/Trospium Chloride, Drug: Valproic Acid |
| Part C | Experimental | Drug: Xanomeline/Trospium Chloride, Drug: Lithium |
| Part D | Experimental | Drug: Xanomeline/Trospium Chloride, Drug: Valproic Acid |
| Part E | Experimental | Drug: Xanomeline/Trospium Chloride, Drug: Lamotrigine |
| Part F | Experimental | Drug: Xanomeline/Trospium Chloride, Drug: Lamotrigine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female [individual not of childbearing potential (INOCBP)] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations.
- BMI of 18.0 to 32.0 kg/m2, inclusive.
Key exclusion criteria (6 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded.
- Parts B and D only: History of pancreatitis.
- Any significant acute or chronic medical illness, in the opinion of the investigator.
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
- Parts E \& F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome
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 ChlorideAlso: BMS-986510, KarXTSpecified dose on specified days | Drug | Part A, Part B, Part C, Part D, Part E, Part F |
| LithiumSpecified dose on specified days | Drug | Part A, Part C |
| Valproic AcidSpecified dose on specified days | Drug | Part B, Part D |
| LamotrigineSpecified dose on specified days | Drug | Part E, Part F |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to day 54
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to day 54
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to day 54
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 28 days post discontinuation of dosing
Number of participants with serious adverse events (SAEs)
Time frame: Up to 28 days post discontinuation of dosing
Number of participants with physical examination abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with vital sign abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with clinical laboratory abnormalities
Time frame: Up to 2 days post discontinuation of dosing
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 2 days post discontinuation of dosing
Number of participants with AEs of Special Interest (AESIs)
Time frame: Up to 28 days post discontinuation of dosing
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 24 Feb 2026.
- 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 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. This study is not recruiting at the moment.
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, Lithium and Valproic Acid in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site 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 2 inclusion and 6 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 24 Feb 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 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to day 54). 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 24 Feb 2026.