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NOT YET RECRUITING
NCT07681076
PHASE4

Study to Assess Safety and Tolerability of KarXT With Administration of Antiemetics in Healthy Volunteers

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View on ClinicalTrials.gov

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

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

Trimethobenzamide

Specified dose on specified days

DRUG

Ondansetron

Specified dose on specified days

DRUG

Meclizine

Specified dose on specified days