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Bored Studies
RecruitingAccepts healthy volunteersPhase 4

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

Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT07681076

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
180
US sites recruiting
4
Study start
September 3, 2026
Record last updated
October 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: KarXT; Trimethobenzamide; Ondansetron; Meclizine

Conditions: Healthy Volunteers

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS

    Los Alamitos, CA 90720

    Site contact: David Walling, Site 0004 · 714-799-7799

  • CenExel RCA - Hollywood

    Hollywood, FL 33024-2639

    Site contact: Edwin Gomez, Site 0002 · 954-604-3900

  • Atlanta Center for Medical Research - CenExel ACMR - PPDS

    Atlanta, GA 30331

    Site contact: Elyssa Barron, Site 0001 · 404-881-5800

  • iResearch Atlanta - CenExel - PPDS

    Decatur, GA 30030

    Site contact: Kimball Johnson, Site 0003 · 404-537-1281

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.