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NOT YET RECRUITING
NCT07454291
PHASE1

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

Sponsor: Endeavor Biomedicines, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

26 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

57

Start Date

2026-03

Completion Date

2026-10

Last Updated

2026-03-06

Healthy Volunteers

Yes

Interventions

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

Locations (2)

Research Site

Brisbane, Queensland, Australia

Research Site

Melbourne, Victoria, Australia