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

Recruiting now · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07204418

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

56

Starts

2025-10-13

Expected to finish

2026-12-03

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States (enrolling)
• ICON - Lenexa — Lenexa, Kansas, United States (enrolling)
• ICON Development Solutions — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.