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

NCT06729970 | Completed Phase 1 FDA Drug

• 1 other identifier: CN012-0035
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

KarXT; Lithium; Valproic acid; Drug-Drug Interaction study; Healthy Volunteers; BMS-986510; Pharmacokinetics; Lamotrigine

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Up to day 54

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to day 54

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

  Up to day 54

Secondary Outcomes (8)

• Number of participants with adverse events (AEs)

  Up to 28 days post discontinuation of dosing

• Number of participants with serious adverse events (SAEs)

  Up to 28 days post discontinuation of dosing

• Number of participants with physical examination abnormalities

  Up to 2 days post discontinuation of dosing

• Number of participants with vital sign abnormalities

  Up to 2 days post discontinuation of dosing

• Number of participants with 12-lead electrocardiogram (ECG) abnormalities

  Up to 2 days post discontinuation of dosing

Study Arms (6)

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

Interventions

Xanomeline/Trospium Chloride DRUG

Specified dose on specified days

Also known as: BMS-986510, KarXT

Part A; Part B; Part C; Part D; Part E; Part F

Lithium DRUG

Specified dose on specified days

Part A; Part C

Valproic Acid DRUG

Specified dose on specified days

Part B; Part D

Lamotrigine DRUG

Specified dose on specified days

Part E; Part F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (1)

Local Institution - 0001

Los Alamitos, California, 90720-3115, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

xanomeline; trospium chloride; Lithium; Valproic Acid; Lamotrigine

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel A \& B cohorts, then Parallel C \& D cohorts and then parallel E\&F cohorts

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 26, 2024
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)