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

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

Recruiting
18-65 years
All
Phase 1

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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.

Eligibility

Inclusion Criteria:

  • 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.
  • Participant must be a normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizer.
  • Participant must have body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.

Exclusion Criteria:

  • 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.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study details
    Healthy Volunteers

NCT07204418

Karuna Therapeutics

1 February 2026

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