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

February 20, 2026 updated by: Karuna Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Alamitos, California, United States, 90720-3115
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510
Drug: Lithium
Specified dose on specified days
Experimental: Part B
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510
Drug: Valproic Acid
Specified dose on specified days
Experimental: Part C
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510
Drug: Lithium
Specified dose on specified days
Experimental: Part D
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510
Drug: Valproic Acid
Specified dose on specified days
Experimental: Part E
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510
Drug: Lamotrigine
Specified dose on specified days
Experimental: Part F
Drug: Xanomeline/Trospium Chloride
Specified dose on specified days
Other Names:
  • KarXT
  • BMS-986510
Drug: Lamotrigine
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to day 54
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
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
Up to day 54

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with physical examination abnormalities
Time Frame: Up to 2 days post discontinuation of dosing
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
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
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
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
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
Up to 28 days post discontinuation of dosing
Number of participants with adverse events (AEs)
Time Frame: Up to 28 days post discontinuation of dosing
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
Up to 28 days post discontinuation of dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karuna Therapeutics

Collaborators

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2024

Primary Completion (Actual)

January 23, 2026

Study Completion (Actual)

January 23, 2026

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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