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