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

NCT07454291 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-05-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Endeavor Biomedicines, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Lancaster, M.D. · Endeavor Biomedicines

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
26 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454291 on ClinicalTrials.gov