A Phase 1, Open-label, 4-Part Study of Leramistat Drug Interactions with CYP3A4, Simvastatin, and Upadacitinib in Healthy Adults

What this Trial Is About

This trial investigates the pharmacokinetics of leramistat, focusing on how its absorption, distribution, metabolism, and elimination are affected by other drugs. Researchers aim to evaluate the effects of CYP3A4 enzyme inhibition and induction on leramistat, as well as interactions between leramistat and other medications such as simvastatin and upadacitinib. The study is a Phase 1, open-label, randomized design conducted in healthy adult volunteers aged 18 to 55 years. The trial consists of four parts, each assessing different drug interactions. Participants will receive oral capsules of leramistat 40 mg along with either itraconazole 200 mg, phenytoin 100 mg, simvastatin 40 mg, or upadacitinib 15 mg. Each part evaluates the pharmacokinetic changes caused by these active comparator drugs taken in fixed sequences. The study is open-label, meaning both researchers and participants know which treatments are administered. Participants will be monitored over 8.5 weeks, during which various pharmacokinetic measures of leramistat will be assessed, including area under the curve (AUC), maximum concentration (Cmax), time to maximum concentration (Tmax), elimination rate, half-life, plasma clearance, and volume of distribution. Researchers will also track any adverse events throughout the study. Healthy adult volunteers will undergo regular evaluations to ensure safety and to collect pharmacokinetic data, contributing to understanding drug interactions with leramistat.

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects