A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adults

What this Trial Is About

This study involves healthy adult volunteers aged 18 to 50 years and aims to evaluate how the drug KarXT affects the levels of three other drugs midazolam, fexofenadine, and digoxin. Researchers want to understand the changes in drug concentration and exposure when these medications are taken together. The study is a Phase 1, open-label trial sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company, focusing on pharmacokinetics in healthy participants. The trial is divided into three parts plus an additional part 1a, where participants will receive specified doses of KarXT along with midazolam, fexofenadine, or digoxin on designated days. Each part evaluates how KarXT alters the maximum observed plasma concentration and the area under the concentration-time curve of each drug, up to approximately day 24. The study is non-randomized and unblinded, with all participants receiving the active drugs under controlled conditions. Participants will undergo medical history review, physical exams, vital signs monitoring, ECGs, and laboratory tests to assess safety and drug effects. Researchers will track adverse events and specific safety concerns up to about day 47. The primary measurements focus on changes in drug levels, while secondary outcomes include monitoring for any abnormal clinical findings or suicidal thoughts using standardized assessments. Overall participation lasts for several weeks, allowing detailed observation of drug interactions and safety in healthy adults.

A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin