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

Karuna Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Xanomeline/ Trospium Chloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT07204418

CN012-0012

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.