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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Xanomeline/ Trospium Chloride

    Drug

    Specified dose on specified days

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: KarXTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Number of participants with Adverse Events (AEs)

Time frame
Up to 28 days post last dose
2

Number of participants with Serious Adverse Events (SAEs)

Time frame
Up to 28 days post last dose
3

Number of participants with physical examination abnormalities

Time frame
Up to 28 days post last dose
4

Number of participants with vital sign abnormalities

Time frame
Up to 28 days post last dose

Other outcomes

Sponsors and contacts

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