Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 4
Started
2026-09-03
Last updated
2026-09-18
Condition(s) studied
Healthy Volunteers
Investigational drug(s) / intervention(s)
KarXTTrimethobenzamideOndansetronMeclizine
KarXT: Specified dose on specified days
Trimethobenzamide: Specified dose on specified days
Ondansetron: Specified dose on specified days
Meclizine: Specified dose on specified days
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
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.
Primary outcome measure(s)
Number of participants with Treatment Emergent Adverse Events (TEAEs) — Up to Day 21 Nausea and vomiting
Trial sites (4)
Facility
City
Region
Status
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
Los Alamitos
California
Recruiting
CenExel RCA - Hollywood
Hollywood
Florida
Recruiting
Atlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta
Georgia
Recruiting
iResearch Atlanta - CenExel - PPDS
Decatur
Georgia
Recruiting
More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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