Recruiting

KarXT with Anti-Nausea

Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Code:

NCT07681076

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

KarXT

Trimethobenzamide

Ondansetron

Meclizine

Study Details

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

Study ID

NCT07681076

Start date

Sep 3, 2026

Status verified date

Sep, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

experimental: Arm 2

experimental: Arm 3

experimental: Arm 4

Interventions

KarXT

Specified dose on specified days

Trimethobenzamide

Specified dose on specified days

Ondansetron

Specified dose on specified days

Meclizine

Specified dose on specified days

Primary outcome measure

  • Number of participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 21 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS

Recruiting

Los Alamitos, California, United States, 90720

Contacts

David Walling, Site 0004

714-799-7799

CenExel RCA - Hollywood

Recruiting

Hollywood, Florida, United States, 33024-2639

Contacts

Edwin Gomez, Site 0002

954-604-3900

Atlanta Center for Medical Research - CenExel ACMR - PPDS

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Elyssa Barron, Site 0001

404-881-5800

iResearch Atlanta - CenExel - PPDS

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Kimball Johnson, Site 0003

404-537-1281

More Information

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.