A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) 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.

NCT Number	NCT07454291
Lead Sponsor	Endeavor Biomedicines, Inc.
Conditions	Idiopathic Pulmonary Fibrosis
Enrollment	57 participants
Start Date	2026-04-28
Primary Completion	2026-10 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-15