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
Xanomeline/Trospium Chloride Capsule: Specified dose on specified days
Xanomeline Enteric Capsule: Specified dose on specified days
Trospium Chloride: Specified dose on specified days
Xanomeline MR: Specified dose on specified days
Xanomeline: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
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
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
Columbia-Suicide Severity Rating Scale (C-SSRS) — Up to Day 14
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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