NCT07454291

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Endeavor Biomedicines, Inc. · Industry
• Sex: All
• Age: 26 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	taladegib	low, medium or high dose tablet administered once, or once a day
DRUG	Nintedanib	150 mg capsule administered twice a day
DRUG	Pirfenidone	One, two or three 267 mg tablets administered three times a day
DRUG	Pirfenidone	Three 267 mg tablets administered once

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study