Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT07681076
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 #.
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