Health Trials

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

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBristol-Myers Squibb

About this trial

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 criteria

Qualifiers

BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.

Other protocol-defined Inclusion/

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Xanomeline/Trospium Chloride Capsule
  • Xanomeline Enteric Capsule
  • Trospium Chloride
  • Xanomeline MR
  • Xanomeline
  • Placebo

Treatment groups

236 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov