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Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
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.
Official title: A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2026-08-03
Completion Date
2026-11-30
Last Updated
2026-07-02
Healthy Volunteers
Yes
Conditions
Interventions
KarXT
Specified dose on specified days
Trimethobenzamide
Specified dose on specified days
Ondansetron
Specified dose on specified days
Meclizine
Specified dose on specified days