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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2026-02-24

No results posted yet for this study

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

Interventions

DRUG

Xanomeline/Trospium Chloride

Specified dose on specified days

DRUG

Lithium

Specified dose on specified days

DRUG

Valproic Acid

Specified dose on specified days

DRUG

Lamotrigine

Specified dose on specified days

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Karuna Therapeutics

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-26
Primary Completion
2026-01-23
Completion
2026-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729970 on ClinicalTrials.gov