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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Xanomeline/ Trospium Chloride

Treatment groups

56 Participants
are divided into 1 treatment group