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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Trial sites expanded: 0 → 4 locations · Start date changed from estimate of Aug 3, 2026 to Sep 3, 2026 · Eligibility criteria expanded, about 9 words Show 3 more changesShow less
    • Trial sites expanded: 0 → 4 locations
    • Start date changed from estimate of Aug 3, 2026 to Sep 3, 2026
    • Eligibility criteria expanded, about 9 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07681076
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Healthy Volunteers
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov