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

Phase 1RecruitingNCT07063342

Bristol-Myers Squibb72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Xanomeline/Trospium Chloride CapsuleDRUG

Specified dose on specified days

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax)

Time frame: Up to Day 23

Time of maximum observed concentration (Tmax)

Time frame: Up to Day 23

Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

Time frame: Up to Day 23

Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time frame: Up to Day 23

Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

Time frame: Up to Day 23

Concentration at the end of a dosing interval (Ctau)

Time frame: Up to Day 23

Apparent total body clearance (CLT/F)

Time frame: Up to Day 23

Effective elimination half-life during dosing interval (T-HALF(eff))

Time frame: Up to Day 23