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

NCT07681076 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-07-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

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

Sponsors & Collaborators

  • Karuna Therapeutics, Inc., a Bristol Myers Squibb company

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07681076 on ClinicalTrials.gov