A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants
The purposes of this study are to: 1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and 2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib). This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.
• Participants are reproductively sterile.
• Body Mass Index (BMI) ≥ 18.5 and ≤ 32 kg/m2 and body weight ≥ 50 kg at study start.
• Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or electrocardiograms (ECGs) prior to dosing, as deemed by the Investigator.
• Able to swallow multiple capsules and tablets.
• Participants are willing to remain on study treatment for the duration of the study and comply with all study days and procedures.
• Participants willing to sign and have a full understanding of the informed consent.
• Participants must be willing to be sequestered for the time period indicated for their respective cohort.