A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- 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, bil…
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
Location
- ICON - LenexaLenexa, Kansas