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Clinical trial

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)

NCT06605950 is registered in ClinicalTrials.gov with Karuna Therapeutics, Inc., a Bristol Myers Squibb company as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 1
Overall status
Completed
Start date
October 1, 2024
Completion date
May 31, 2025
Enrollment
78 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy volunteers