A Phase 1, Open-label, 3-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat and to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

IST-05

A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects.

2024-04-08

2024-05-31

2024-09-30

Recruiting

Early phase I

36

Principal Inclusion Criteria: Healthy, adult, male or female of non childbearing potential 18 to 55 years of age. Principal Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2024-05-07