A Phase 4 interventional study of KarXT and Trimethobenzamide in Healthy Volunteers, sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company (part of Bristol-Myers Squibb) · Phase 4, Interventional, and Treatment
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.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 180 is above the median of 96 across 544 interventional studies indexed under Nausea.
Browse Nausea studies →Karuna Therapeutics, Inc., a Bristol Myers Squibb company is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
First submitted after Karuna Therapeutics, Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KarXT · Drug: Trimethobenzamide
Drug: KarXT · Drug: Ondansetron
Drug: KarXT · Drug: Meclizine
Drug: KarXT
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: Xanomeline/Trospium Chloride, BMS-986510
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Nausea and vomiting
Time frame: Up to Day 21
Number of participants with TEAEs
Nausea and vomiting
Time frame: Up to Day 14
Time to first onset of nausea and vomiting
Time frame: Up to Day 21
Time to resolution of first episode of nausea or vomiting
Time frame: Up to Day 21
Number of participants with TEAEs
Time frame: Up to Day 28
Number of participants with serious TEAEs
Time frame: Up to Day 28
Number of participants with Adverse Events of Special Interests (AESIs)
Time frame: Up to Day 28
Number of participants with TEAEs leading to discontinuation
Time frame: Up to Day 28
Number of participants with clinically abnormal Vital signs
Time frame: Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 21
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Xanomeline · Trospium
Karuna Therapeutics, Inc., a Bristol Myers Squibb company →