drugset / Trial / NCT07454291
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2026-04-28
- Primary completion
- 2026-10
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | 150 mg | — |
| Subject | Pirfenidone | Small molecule | 267 mg | — |
| Subject | taladegib | Small molecule | — | — |