Healthy Volunteers
Conditions
Keywords
Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, Midazolam, Fexofenadine, Digoxin, Drug-drug interaction
Brief summary
The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGMidazolam
Specified dose on specified days
DRUGFexofenadine
Specified dose on specified days
DRUGDigoxin
Specified dose on specified days
Sponsors
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations. * Participants must have BMI of 18.0 to 32.0 kg/m2.
Exclusion criteria
* Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges. * Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results. * Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator. * Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia. * Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure). * Participants must not have any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). * Participants must not have history of active GI obstructive disorder. * Participants must not have history of bladder stones. * Participants must not have history of recurrent urinary tract infections. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT | Up to approximately day 24 |
| Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT | Up to approximately day 24 |
| Part 2: GMR of Cmax of fexofenadine with and without KarXT | Up to approximately day 24 |
| Part 2: GMR of AUC of fexofenadine with and without KarXT | Up to approximately day 24 |
| Part 3: GMR of Cmax of digoxin with and without KarXT | Up to approximately day 24 |
| Part 3: GMR of AUC of digoxin with and without KarXT | Up to approximately day 24 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to approximately day 47 |
| Number of participants with serious adverse events (SAEs) | Up to approximately day 47 |
| Number of participants with physical examination abnormalities | Up to approximately day 24 |
| Number of participants with vital sign abnormalities | Up to approximately day 24 |
| Number of participants with 12-lead electrocardiogram abnormalities (ECGs) | Up to approximately day 24 |
| Number of participants with clinical laboratory assessment abnormalities | Up to approximately day 24 |
| Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately day 24 |
| Number of participants with adverse event of special interest (AESIs) | Up to approximately day 47 |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed