NCT07454291 A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
| NCT ID | NCT07454291 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Endeavor Biomedicines, Inc. |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2026-04-28 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 57 participants in total. It began in 2026-04-28 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Lisa Lancaster, M.D.
STUDY DIRECTOR
Endeavor Biomedicines
Frequently Asked Questions
Who can join the NCT07454291 clinical trial?
This trial is open to participants of all sexes, aged 26 Years or older, up to 65 Years, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07454291 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07454291 currently recruiting?
Yes, NCT07454291 is actively recruiting participants. Contact the research team at ebmclinical@endeavorbiomedicines.com for enrollment information.
Where is the NCT07454291 trial being conducted?
This trial is being conducted at Brisbane, Australia, Melbourne, Australia.
Who is sponsoring the NCT07454291 clinical trial?
NCT07454291 is sponsored by Endeavor Biomedicines, Inc.. The principal investigator is Lisa Lancaster, M.D. at Endeavor Biomedicines. The trial plans to enroll 57 participants.