See if ENV-101 interacts with IPF medicines like nintedanib and pirfenidone
Official title: A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants
Run by Endeavor Biomedicines, Inc. · NCT07454291 · Data updated 2026-11-12
This study tests whether taladegib (ENV-101) changes how IPF drugs work in healthy people to see if there are drug interactions and to describe how the drug moves through the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 26 Years to 65 Years |
| Sex | All |
| Enrollment | 57 (estimated) |
| Sponsor | Endeavor Biomedicines, Inc. Industry-sponsored |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT07454291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults who are reproductively sterile, have BMI 18.5–32 kg/m2, weigh at least 50 kg, can swallow capsules, and are willing to be sequestered for the study duration.
✕Probably not a fit
Individuals with significant medical history or current medications, or those unable to adhere to sequestration requirements, may not benefit and could be excluded for safety reasons.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human trial investigates potential drug–drug interactions between taladegib (ENV-101) and standard IPF therapies (nintedanib and pirfenidone) and characterizes taladegib pharmacokinetics. Four cohorts receive taladegib alone or with the IPF medicines over up to 30 days, followed by a 14-day safety follow-up. Participants are healthy volunteers who must meet strict inclusion criteria and be sequestered during treatment. The study uses a phased, controlled design to understand absorption, distribution, metabolism, and excretion of taladegib in this context.
Why it matters
Potential benefit: If successful, the study could clarify safety and dosing considerations for future IPF-focused research involving ENV-101.
How similar studies have gone: Prior pharmacokinetic and drug–drug interaction studies in healthy volunteers have informed similar IPF-related compound assessments, though this exact ENV-101 combination and design is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants are reproductively sterile. * Body Mass Index (BMI) ≥ 18.5 and ≤ 32 kg/m2 and body weight ≥ 50 kg at study start. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or electrocardiograms (ECGs) prior to dosing, as deemed by the Investigator. * Able to swallow multiple capsules and tablets. * Participants are willing to remain on study treatment for the duration of the study and comply with all study days and procedures. * Participants willing to sign and have a full understanding of the informed consent. * Participants must be willing to be sequestered for the time period indicated for their respective cohort. Exclusion Criteria: * Chronic or current use of any prescription or over the counter medications; or acute use of prescription medications within 14 days or 5 half-lives, whichever is longer, or over the counter medications within 7 days or 5 half-lives, whichever is longer, prior to study start, or planned use during all study periods. * Participant is unwilling to refrain from fruits (including juices) that inhibit CYP3A4, including grapefruit, Seville orange, pomelo, or star fruit, beginning 7 days prior to study start through end of study. * Active infection with hepatitis B or C, or human immunodeficiency virus (HIV) during screening. * Current alcohol or drug abuse. * Smoking or other nicotine use (including but not limited to vaping, nicotine patch, nicotine gum or nicotine lozenge) within 3 months prior to screening, current smoker, or unwillingness to refrain from smoking for the duration of the study. * History or presence (per participant history) of: 1. Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus 2. Thrombophlebitis or deep vein thrombosis 3. Hematologic or coagulation disorders 4. Liver disease or dysfunction; Gilbert's syndrome 5. Renal dysfunction or glomerulonephritis 6. Coronary artery disease 7. Diverticular disease 8. Congestive heart failure or ventricular dysfunction 9. Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the Investigator. * History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers, within 5 years before study start. * Participation in a clinical research trial that included the receipt of an investigational agent or any experimental procedure within 30 days or 5 half-lives, whichever is longer, prior to screening, during screening, or planned participation in any such trial while participating in this study. * Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to screening, or planned during the course of the trial. * Participants with clinically significant cardiac abnormalities including but not limited to: has pacemaker; or is not in sinus rhythm during screening; or has a left bundle branch block or bifascicular block during screening; or any prior history of ventricular arrhythmia or torsades de pointes. * Participant is unwilling to adhere to the on-study diet provided by the clinical site during study participation. * Females who are pregnant or nursing. * Participants that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of any study treatment. * Males who are unwilling to refrain from sperm donation for the duration of the study and for 95 days after their final dose of any study treatment. * Females who are unwilling to refrain from egg donation for the duration of the study and for 95 days after their final dose of any study treatment. * Participants with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of taladegib (all cohorts), nintedanib (Cohort 1), or pirfenidone (Cohorts 2 and 3). * Participants who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor.
Where it's running
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Research Site
Brisbane, Queensland, Australia Recruiting -
Research Site
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Endeavor Clinical Trials
- Email: ebmclinical@endeavorbiomedicines.com
- Phone: 1-858-727-3199
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.