Healthy Volunteers
Conditions
Keywords
Japanese, Elderly, Adult, Healthy, Pharmacokinetics, BMS-986510, BMS-986519, KarXT, Omeprazole, Drug interaction
Brief summary
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.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
DRUGOmeprazole
Specified dose on specified days
Sponsors
Karuna Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part 1 of this study is double-blind while Part 2 is open-label.
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal elimination half-life (T-HALF) | Up to Day 29 | Part 2 |
| Number of participants with Adverse Events (AEs) | Up to 28 days post last dose | Part 1 |
| Number of participants with Serioues AEs (SAEs) | Up to 28 days post last dose | Part 1 |
| Number of participants with vital sign abnormalities | Up to 28 days post last dose | Part 1 |
| Body weight | Up to 28 days post last dose | Part 1 |
| Number of participants with 12-lead electrocardiogram abnormalities | Up to 28 days post last dose | Part 1 |
| Number of participants with physical examination abnormalities | Up to 28 days post last dose | Part 1 |
| Number of participants with clinical laboratory assessment abnormalities | Up to 28 days post last dose | Part 1 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | On Day 30 | Part 1 |
| Maximum observed plasma concentration (Cmax) | Up to Day 29 | Part 2 |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 29 | Part 2 |
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to Day 29 | Part 2 |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)) | Up to Day 29 | Part 2 |
| Apparent total body clearance (CLT/F) | Up to Day 29 | Part 2 |
| Apparent volume of distribution (Vz/F) | Up to Day 29 | Part 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with 12-lead electrocardiogram abnormalities | Up to 28 days post last dose | Part 2 |
| T-HALF | Up to Day 29 | Part 1 |
| Number of participants with physical examination abnormalities | Up to 28 days post last dose | Part 2 |
| Number of participants with clinical laboratory assessment abnormalities | Up to 28 days post last dose | Part 2 |
| C-SSRS | On Day 30 | Part 2 |
| Number of participants with AEs | Up to 28 days post last dose | Part 2 |
| Number of participants with SAEs | Up to 28 days post last dose | Part 2 |
| Number of participants with vital sign abnormalities | Up to 28 days post last dose | Part 2 |
| Body weight | Up to 28 days post last dose | Part 2 |
| Cmax | Up to Day 29 | Part 1 |
| Tmax | Up to Day 29 | Part 1 |
| AUC(0-24) | Up to Day 29 | Part 1 |
| AUC(TAU) | Up to Day 29 | Part 1 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to Day 29 | Part 1 |
| CLT/F | Up to Day 29 | Part 1 |
| Vz/F | Up to Day 29 | Part 1 |
Countries
United States
Outcome results
None listed