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

Part of paid clinical trials in Los Alamitos, California.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT07681076
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • KarXT — DRUG
    Specified dose on specified days
  • Trimethobenzamide — DRUG
    Specified dose on specified days
  • Ondansetron — DRUG
    Specified dose on specified days
  • Meclizine — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Sep 3, 2026
Status verified
Sep 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
  • Experimental: Arm 2
  • Experimental: Arm 3
  • Experimental: Arm 4

Primary Outcome Measure

Number of participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 21 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (4)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDSLos AlamitosCalifornia90720
David Walling, Site 0004
714-799-7799
CenExel RCA - HollywoodHollywoodFlorida33024-2639
Edwin Gomez, Site 0002
954-604-3900
Atlanta Center for Medical Research - CenExel ACMR - PPDSAtlantaGeorgia30331
Elyssa Barron, Site 0001
404-881-5800
iResearch Atlanta - CenExel - PPDSDecaturGeorgia30030
Kimball Johnson, Site 0003
404-537-1281

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Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS· Los Alamitos, CACenExel RCA - Hollywood· Hollywood, FLAtlanta Center for Medical Research - CenExel ACMR - PPDS· Atlanta, GAiResearch Atlanta - CenExel - PPDS· Decatur, GA

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