Healthy Volunteers
Conditions
Keywords
KarXT, Lithium, Valproic acid, Drug-Drug Interaction study, Healthy Volunteers, BMS-986510, Pharmacokinetics, Lamotrigine
Brief summary
The purpose of this study is to evaluate the effects of lithium, valproic acid, and lamotrigine on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium, valproic acid, and lamotrigine in healthy participants.
Interventions
Specified dose on specified days
DRUGLithium
Specified dose on specified days
DRUGValproic Acid
Specified dose on specified days
DRUGLamotrigine
Specified dose on specified days
Sponsors
Karuna Therapeutics
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel A & B cohorts, then Parallel C & D cohorts and then parallel E&F cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female \[individual not of childbearing potential (INOCBP)\] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations. * BMI of 18.0 to 32.0 kg/m2, inclusive.
Exclusion criteria
* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded. * Parts B and D only: History of pancreatitis. * Any significant acute or chronic medical illness, in the opinion of the investigator. * History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia. * Parts E \& F only: history of skin rash and mucus ulcerations of no obvious cause and Gilbert's syndrome * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to day 54 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to day 54 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Up to day 54 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 28 days post discontinuation of dosing |
| Number of participants with serious adverse events (SAEs) | Up to 28 days post discontinuation of dosing |
| Number of participants with physical examination abnormalities | Up to 2 days post discontinuation of dosing |
| Number of participants with vital sign abnormalities | Up to 2 days post discontinuation of dosing |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to 2 days post discontinuation of dosing |
| Number of participants with clinical laboratory abnormalities | Up to 2 days post discontinuation of dosing |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 2 days post discontinuation of dosing |
| Number of participants with AEs of Special Interest (AESIs) | Up to 28 days post discontinuation of dosing |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed