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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

NCT ID: NCT06729970

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-26

Study Completion Date

2026-01-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel A \& B cohorts, then Parallel C \& D cohorts and then parallel E\&F cohorts
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Lithium

Intervention Type DRUG

Specified dose on specified days

Part B

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Valproic Acid

Intervention Type DRUG

Specified dose on specified days

Part C

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Lithium

Intervention Type DRUG

Specified dose on specified days

Part D

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Valproic Acid

Intervention Type DRUG

Specified dose on specified days

Part E

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Lamotrigine

Intervention Type DRUG

Specified dose on specified days

Part F

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Lamotrigine

Intervention Type DRUG

Specified dose on specified days

Interventions

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Xanomeline/Trospium Chloride

Specified dose on specified days

Intervention Type DRUG

Lithium

Specified dose on specified days

Intervention Type DRUG

Valproic Acid

Specified dose on specified days

Intervention Type DRUG

Lamotrigine

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986510 KarXT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karuna Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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CenExel Collaborative Neuroscience Research, LLC - Los Alamitos

Los Alamitos, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

[email protected]
855-907-3286

First line of the email MUST contain the NCT# and Site #.

Role: CONTACT

Facility Contacts

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Steven Reynolds, Site 0001

Role: primary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06729970.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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CN012-0035

Identifier Type: -

Identifier Source: org_study_id

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