A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline; Drug: Trospium Chloride; Drug: Xanomeline MR; Drug: Xanomeline Enteric Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT07063342

CN012-0043

IRAS1011809 (Registry Identifier)

U1111-1321-3511 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

236 participants in 6 patient groups

Part 1

Experimental group

Treatment:

Drug: Xanomeline Enteric Capsule

Drug: Trospium Chloride

Drug: Xanomeline/Trospium Chloride Capsule

Part 2

Experimental group

Treatment:

Drug: Xanomeline MR

Drug: Xanomeline Enteric Capsule

Drug: Xanomeline/Trospium Chloride Capsule

Part 3a

Experimental group

Treatment:

Drug: Xanomeline Enteric Capsule

Drug: Xanomeline/Trospium Chloride Capsule

Part 3b

Experimental group

Treatment:

Drug: Xanomeline MR

Drug: Xanomeline Enteric Capsule

Drug: Xanomeline/Trospium Chloride Capsule

Part 4a

Experimental group

Treatment:

Drug: Xanomeline

Drug: Xanomeline/Trospium Chloride Capsule

Drug: Placebo

Part 4b

Experimental group

Treatment:

Drug: Xanomeline

Drug: Xanomeline/Trospium Chloride Capsule

Drug: Placebo