Healthy Volunteers
Conditions
Keywords
Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, CYP2D6
Brief summary
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.
Interventions
DRUGXanomeline/ Trospium Chloride
Specified dose on specified days
Sponsors
Karuna Therapeutics
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12)) | Up to Day 17 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 28 days post last dose |
| Number of participants with clinical laboratory test abnormalities | Up to 28 days post last dose |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 28 days post last dose |
| Number of participants with AEs of Special Interest (AESIs) | Up to 28 days post last dose |
| Number of participants with Adverse Events (AEs) | Up to 28 days post last dose |
| Number of participants with Serious Adverse Events (SAEs) | Up to 28 days post last dose |
| Number of participants with vital sign abnormalities | Up to 28 days post last dose |
| Number of participants with physical examination abnormalities | Up to 28 days post last dose |
Countries
United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain the NCT# and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed