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Trial ID CN012-0012  |   NCT07204418

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-65
    Age Range
  • 3
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Participant must be healthy male and female (INOCBP) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (VS), and clinical laboratory determinations.
    1. Participant must be a normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizer.
      1. Participant must have body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.

        Exclusion Criteria

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        :
        • Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
          Additional Information *
          • Other protocol-defined Inclusion/Exclusion criteria apply.

            Treatment Options

            Study Arms

            ASSIGNED INTERVENTION

            Study Arms

            Experimental: KarXT

            ASSIGNED INTERVENTION
            • Drug: Xanomeline/ Trospium Chloride
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