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NCT Number: NCT07681076

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KarXT

Drug

Specified dose on specified days

Other names: Xanomeline/Trospium Chloride, BMS-986510

Trimethobenzamide

Drug

Specified dose on specified days

ondansetron

Drug

Specified dose on specified days

Meclizine

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 21

    Nausea and vomiting

Secondary outcomes

  1. Number of participants with TEAEs

    Time frame: Up to Day 14

    Nausea and vomiting

  2. Time to first onset of nausea and vomiting

    Time frame: Up to Day 21

  3. Time to resolution of first episode of nausea or vomiting

    Time frame: Up to Day 21

  4. Number of participants with TEAEs

    Time frame: Up to Day 28

  5. Number of participants with serious TEAEs

    Time frame: Up to Day 28

  6. Number of participants with Adverse Events of Special Interests (AESIs)

    Time frame: Up to Day 28

  7. Number of participants with TEAEs leading to discontinuation

    Time frame: Up to Day 28

  8. Number of participants with clinically abnormal Vital signs

    Time frame: Up to Day 28

  9. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 21

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study title

A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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