Actively Recruiting
A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-Drug Interactions of ENV-101 (Taladegib) in Healthy Adults
Led by Endeavor Biomedicines, Inc. · Updated on 2026-05-15
57
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying idiopathic pulmonary fibrosis (IPF) by evaluating how the investigational drug taladegib (ENV-101) interacts with current standard treatments, nintedanib and pirfenidone. The study also aims to understand how taladegib is absorbed, distributed, metabolized, and eliminated by the body. This phase 1, open-label study involves healthy adult participants and is sponsored by Endeavor Biomedicines, Inc. The study consists of four groups, each receiving different treatment regimens. One group takes nintedanib twice daily to observe its impact on a single dose of taladegib. Another group takes pirfenidone three times daily for this purpose. A third group receives multiple days of taladegib to assess its effect on a single dose of pirfenidone. The last group receives a single dose of taladegib to measure its pharmacokinetic profile. Each group undergoes treatment for up to 30 days, followed by a 14-day safety follow-up period. Participants will stay at the clinical site for a specified time depending on their group, during which they will take the study drugs as scheduled. Researchers will measure drug levels in the blood at various time points to assess absorption and elimination characteristics. Safety evaluations will continue during the follow-up period after treatment ends. Overall, the study duration varies by cohort, with the longest treatment lasting 30 days plus 14 days of follow-up, ensuring careful monitoring of drug interactions and participant safety.
CONDITIONS
Brief Title
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be reproductively sterile.
- Body Mass Index (BMI) between 18.5 and 32 kg/m2 and body weight at least 50 kg at study start.
- Medically healthy with no significant medical history or abnormal test results as determined by the investigator.
- Able to swallow multiple capsules and tablets.
- Willing to remain on study treatment and comply with all study days and procedures.
- Willing to sign informed consent and fully understand the study.
- Willing to be sequestered (housed) for the duration required by their study cohort.
You will not qualify if you...
- Chronic or current use of any prescription or over-the-counter medications within specified timeframes before the study or planned use during the study.
- Unwillingness to avoid fruits that inhibit CYP3A4 (e.g., grapefruit, Seville orange) from 7 days before study start through study end.
- Active infection with hepatitis B, hepatitis C, or HIV.
- Current alcohol or drug abuse.
- Smoking or nicotine use within 3 months before screening or unwillingness to abstain during the study.
- History or presence of autoimmune disease, blood clotting disorders, liver or kidney dysfunction, heart disease, diverticular disease, or other major uncontrolled diseases.
- History of cancer within 5 years except certain skin or cervical cancers.
- Participation in other clinical research with investigational agents within 30 days before screening.
- Major surgery requiring hospitalization within 3 months before screening.
- Significant cardiac abnormalities including pacemaker or arrhythmias.
- Unwillingness to follow the study diet.
- Pregnant or nursing females.
- Unwillingness to refrain from blood, sperm, or egg donation during and after the study.
- History of severe allergic reactions to study drugs.
- Immediate family members of study site personnel or sponsor affiliates.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 days depending on cohort
Participants receive study drugs in different cohorts to evaluate pharmacokinetics and drug-drug interactions. Treatment includes single or multiple doses of taladegib, nintedanib, or pirfenidone depending on cohort assignment.
Multiple visits depending on cohort for dosing and pharmacokinetic assessments
Trial Site Locations
Total: 2 locations
1
Research Site
Brisbane, Queensland, Australia, 4006
Actively Recruiting
2
Research Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
E
Endeavor Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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