Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers

NCT07681076 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: CN012-0182
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed. The goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.

Conditions

Healthy Volunteers

Keywords

BMS-986510; KarXT; Xanomeline/Trospium; Antiemetics; Nausea; Vomiting; Gastrointestinal side effects

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

  Nausea and vomiting

  Up to Day 21

Secondary Outcomes (9)

• Number of participants with TEAEs

  Up to Day 14

• Time to first onset of nausea and vomiting

  Up to Day 21

• Time to resolution of first episode of nausea or vomiting

  Up to Day 21

• Number of participants with TEAEs

  Up to Day 28

• Number of participants with serious TEAEs

  Up to Day 28

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: KarXT; Drug: Trimethobenzamide

Arm 2

EXPERIMENTAL

Drug: KarXT; Drug: Ondansetron

Arm 3

EXPERIMENTAL

Drug: KarXT; Drug: Meclizine

Arm 4

EXPERIMENTAL

Drug: KarXT

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: Xanomeline/Trospium Chloride, BMS-986510

Arm 1; Arm 2; Arm 3; Arm 4

Trimethobenzamide DRUG

Specified dose on specified days

Arm 1

Ondansetron DRUG

Specified dose on specified days

Arm 2

Meclizine DRUG

Specified dose on specified days

Arm 3

Eligibility Criteria

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

You may qualify if:

• Participants must be healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
• Participants must be willing and able to be confined to an inpatient setting for a 3-week duration, follow instructions, and comply with the protocol requirements.
• Participants must have BMI ≥ 18 and ≤ 40 kg/m2.
• Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines.

You may not qualify if:

• Participants must not have history or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (\[GI\] eg, obstructive disorders \[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\], active biliary disease \[including symptomatic gallstones\]), 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.
• Participants must not have history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.
• Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
• Participants must not have active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor.

Sponsors & Collaborators

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

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

xanomeline; trospium chloride; trimethobenzamide; Ondansetron; Meclizine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

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