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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07063342

CN012-0043

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, and to explore the effect of food after multiple doses of selected prototypes in healthy adult participants.

Enrollment: 48 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)

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48 participants in 2 patient groups

Part 1

Experimental group

Treatment:

Drug: Xanomeline/Trospium Chloride Capsule

Drug: Xanomeline Enteric Capsule

Drug: Trospium Chloride

Part 2

Experimental group

Treatment:

Drug: Xanomeline/Trospium Chloride Capsule

Drug: Xanomeline Enteric Capsule

Drug: Trospium Chloride