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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule; Drug: Trospium Chloride

• Registration Number: NCT07063342
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-23
• Study Start: 2025-06-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1	Xanomeline/Trospium Chloride Capsule	-
Part 1	Xanomeline Enteric Capsule	-
Part 1	Trospium Chloride	-
Part 2	Xanomeline/Trospium Chloride Capsule	-
Part 2	Xanomeline Enteric Capsule	-
Part 2	Trospium Chloride	-

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Up to Day 23
Time of maximum observed concentration (Tmax)	Up to Day 23
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Up to Day 23
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to Day 23
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))	Up to Day 23
Concentration at the end of a dosing interval (Ctau)	Up to Day 23
Apparent total body clearance (CLT/F)	Up to Day 23
Effective elimination half-life during dosing interval (T-HALF(eff))	Up to Day 23

Secondary Outcome Measures

Name	Time	Method
Number of participants with Treatment Emergent Adverse Events (TEAEs)	Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)	Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)	Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation	Up to 30 days after final dose of study intervention
Number of participants with vital signs abnormalities	Up to 30 days after final dose of study intervention
Number of participants with electrocardiogram (ECG) abnormalities	Up to 30 days after final dose of study intervention
Number of participants with physical examination abnormalities	Up to 30 days after final dose of study intervention
Number of participants with clinical laboratory abnormalities	Up to 30 days after final dose of study intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to Day 25
Geometric mean ratio of Cmax	Up to Day 23
Geometric mean ratio of AUC(0-T)	Up to Day 23
Geometric mean ratio of AUC(INF)	Up to Day 23
Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))	Up to Day 23

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom