Can Anti-Nausea meds tame KarXT's stomach woes?
NCT ID NCT07681076
First seen Jul 02, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This study tests whether taking anti-nausea medication alongside KarXT—a drug used for schizophrenia—can reduce nausea and vomiting. Healthy volunteers will take KarXT with either scheduled or as-needed antiemetics. The goal is to find a safer, more comfortable way to start treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KarXT (xanomeline/trospium chloride) with antiemetics (trimethobenzamide, ondansetron, meclizine)
- What this could lead to
- If successful, this could help doctors manage nausea and vomiting in patients starting KarXT, making treatment more tolerable and improving adherence.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, not patients. Results may not fully predict real-world side effect management or long-term safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atlanta Center for Medical Research - CenExel ACMR - PPDS
RECRUITINGAtlanta, Georgia, 30331, United States
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CenExel RCA - Hollywood
RECRUITINGHollywood, Florida, 33024-2639, United States
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Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
RECRUITINGLos Alamitos, California, 90720, United States
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iResearch Atlanta - CenExel - PPDS
RECRUITINGDecatur, Georgia, 30030, United States
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