KarXT with antiemetics safety in healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 study examines the safety and tolerability of KarXT when taken with antiemetic medications in healthy volunteers. Participants will receive KarXT with either regular or as-needed antiemetic treatment in an inpatient setting for three weeks. The goal is to see if the combination reduces GI side effects without introducing new safety concerns. Results may guide how to manage KarXT-related nausea during initial treatment in patients with mental health conditions. No patient-focused efficacy outcomes are reported in this healthy volunteer study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS
  Los Alamitos, California, United States Recruiting
• CenExel RCA - Hollywood
  Hollywood, Florida, United States Recruiting
• Atlanta Center for Medical Research - CenExel ACMR - PPDS
  Atlanta, Georgia, United States Recruiting
• iResearch Atlanta - CenExel - PPDS
  Decatur, Georgia, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.