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A 2-Part, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity (Part 1) and an Open-label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride in Healthy Adult Participants (Part 2)

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Trial Profile

A 2-Part, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity (Part 1) and an Open-label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride in Healthy Adult Participants (Part 2)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 23 May 2025

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At a glance

  • Drugs Trospium chloride/xanomeline (Primary) ; Omeprazole
  • Indications Psychotic disorders; Schizophrenia
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Karuna Therapeutics

Most Recent Events

  • 15 May 2025 Planned End Date changed from 21 Apr 2025 to 31 May 2025.
  • 15 May 2025 Planned primary completion date changed from 21 Apr 2025 to 31 May 2025.
  • 22 Oct 2024 Status changed from not yet recruiting to recruiting.

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