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Recruiting NCT07063342

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 I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Trospium Chloride.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 1, 3-Part, Open-label Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants

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.

Interventions

  • Drug Xanomeline/Trospium Chloride Capsule
    Specified dose on specified days
  • Drug Xanomeline Enteric Capsule
    Specified dose on specified days
  • Drug Trospium Chloride
    Specified dose on specified days

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Number of participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with Serious Adverse Events (SAEs) [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with Adverse Events of Special Interest (AESIs) [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with vital signs abnormalities [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with electrocardiogram (ECG) abnormalities [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with physical examination abnormalities [Time frame: Up to 30 days after final dose of study intervention]
  • Number of participants with clinical laboratory abnormalities [Time frame: Up to 30 days after final dose of study intervention]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to Day 25]
  • Geometric mean ratio of Cmax [Time frame: Up to Day 23]
  • Geometric mean ratio of AUC(0-T) [Time frame: Up to Day 23]
  • Geometric mean ratio of AUC(INF) [Time frame: Up to Day 23]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Quotient Sciences — Nottingham

Identifiers

NCT: NCT07063342 · CN012-0043 · U1111-1321-3511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗