A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants
NCT07063342 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-12-19
Summary
The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, and to explore the effect of food after multiple doses of selected prototypes in healthy adult participants.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
- DRUG
-
Xanomeline Enteric Capsule
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-27
- Primary Completion
- 2026-08-15
- Completion
- 2026-08-15
Countries
- United Kingdom
Study Locations
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