drugset / Trial / NCT06605950

A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants

NCT06605950

Phase 1 Completed 78 enrolled Karuna Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.

Timeline

Start
2024-10-01
Primary completion
2025-05-31
Completion
2025-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified
Subject Trospium Small molecule
Subject Xanomeline Small molecule

Indications

No indication recorded.