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Recruiting NCT07204418

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration 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.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 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 States
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

A Phase 1, 4-part, Open-label Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

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.

Interventions

  • Drug Xanomeline/ Trospium Chloride
    Specified dose on specified days

Primary outcome measures

  • Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12)) [Time frame: Up to Day 17]
Secondary outcome measures (8)
  • Number of participants with Adverse Events (AEs) [Time frame: Up to 28 days post last dose]
  • Number of participants with Serious Adverse Events (SAEs) [Time frame: Up to 28 days post last dose]
  • Number of participants with physical examination abnormalities [Time frame: Up to 28 days post last dose]
  • Number of participants with vital sign abnormalities [Time frame: Up to 28 days post last dose]
  • Number of participants with electrocardiogram (ECG) abnormalities [Time frame: Up to 28 days post last dose]
  • Number of participants with clinical laboratory test abnormalities [Time frame: Up to 28 days post last dose]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to 28 days post last dose]
  • Number of participants with AEs of Special Interest (AESIs) [Time frame: Up to 28 days post last dose]

Eligibility criteria

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.

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

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Anaheim Clinical Trials — Anaheim
  • ICON - Lenexa — Lenexa
  • ICON Development Solutions — San Antonio

Identifiers

NCT: NCT07204418 · CN012-0012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗