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Trials / Recruiting

RecruitingNCT07204418

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
56 (estimated)
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGXanomeline/ Trospium ChlorideSpecified dose on specified days

Timeline

Start date
2025-10-13
Primary completion
2026-12-03
Completion
2026-12-03
First posted
2025-10-02
Last updated
2026-02-19

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07204418. Inclusion in this directory is not an endorsement.

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administratio (NCT07204418) · Clinical Trials Directory