A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants

Karuna Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Omeprazole; Drug: KarXT; Drug: KarX-EC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06605950

CN012-0030

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.

Enrollment: 78 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Inclusion Criteria for Healthy Adult Japanese Participants (Group A):.

• Healthy adult participants must be 19 to 55 years of age, inclusive.

  i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.

ii) Must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.

iii) Must have an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the screening visit. One repeat measurement is allowed.

• Inclusion Criteria for Healthy Elderly Japanese Participants (Groups B and C):.

• Healthy elderly participants must be 56 to 90 years of age, inclusive.

  i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.

ii) Must have a BMI ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive), at the time of signing the ICF.

iii) Must have an eGFR of > 60 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.

• Inclusion Criteria for Healthy Adult Participants (Groups D):.

• Healthy adult participants must be 19 to 55 years of age, inclusive.

  i) Participants with any ethnicity can be included.

ii) Must have a BMI of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.

iii) Must have an eGFR of ≥ 90 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.

Exclusion Criteria

• Exclusion Criteria for All Participants (Groups A, B, C, and D):.

i) Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.

ii) History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

iii) Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.

iv) History of cancer that has not been in full remission for >5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for > 1 year prior to the screening visit).

• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 4 patient groups

Group A

Experimental group

Treatment:

Drug: KarXT

Drug: Placebo

Group B

Experimental group

Treatment:

Drug: KarXT

Drug: Placebo

Group C

Experimental group

Treatment:

Drug: KarX-EC

Drug: KarXT

Drug: Placebo

Group D

Experimental group

Treatment:

Drug: KarX-EC

Drug: KarXT

Drug: Omeprazole