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NCT Number: NCT07454291

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

26 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus
  • Thrombophlebitis or deep vein thrombosis
  • Hematologic or coagulation disorders
  • Liver disease or dysfunction; Gilbert's syndrome
  • Renal dysfunction or glomerulonephritis
  • Coronary artery disease
  • Diverticular disease
  • Congestive heart failure or ventricular dysfunction
  • 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.

Treatment and study plan

taladegib

Drug

low, medium or high dose tablet administered once, or once a day

Other names: ENV-101

Nintedanib

Drug

150 mg capsule administered twice a day

pirfenidone

Drug

One, two or three 267 mg tablets administered three times a day

Primary outcomes

  1. Cohort 1: Taladegib (ENV-101) maximum blood concentration (Cmax) after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

  2. Cohort 1: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

  3. Cohort 1: Taladegib absorption to time t (AUC[0-t]) after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

    AUC[0-t] represents "area under the concentration-time curve" and measures the amount of drug that is present in the blood from the time of administration to a given time t

  4. Cohort 1: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

  5. Cohort 1: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

  6. Cohort 1: Taladegib half-life in the blood (T1/2) after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

  7. Cohort 1: Elimination rate constant (K[el]) for taladegib after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

    K[el] represents the fraction of a drug that is removed from the body per unit of time.

  8. Cohort 1: Apparent oral clearance (CL/F) of taladegib after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

    Apparent oral clearance represents the volume of plasma cleared of drug per unit time after oral administration.

  9. Cohort 1: Apparent volume of distribution (Vz/F) of taladegib after administration alone and after coadministration with nintedanib

    Time frame: Day 1 and Day 13

    Apparent volume of distribution signifies how extensively a drug distributes throughout the body, accounting for bioavailability.

  10. Cohort 2: Taladegib maximum blood concentration (Cmax) after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  11. Cohort 2: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  12. Cohort 2: Taladegib absorption to time t (AUC[0-t]) after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  13. Cohort 2: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  14. Cohort 2: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  15. Cohort 2: Taladegib half-life in the blood (T1/2) after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  16. Cohort 2: Elimination rate constant (K[el]) for taladegib after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  17. Cohort 2: Apparent oral clearance (CL/F) of taladegib after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  18. Cohort 2: Apparent volume of distribution (Vz/F) of taladegib after administration alone and after coadministration with pirfenidone

    Time frame: Day 1 and Day 27

  19. Cohort 3: Pirfenidone maximum blood concentration (Cmax) after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  20. Cohort 3: Time of pirfenidone maximum blood concentration (Tmax) after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  21. Cohort 3: Pirfenidone absorption to time t (AUC[0-t]) after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  22. Cohort 3: Pirfenidone total absorption (AUC[0-infinity]) after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  23. Cohort 3: Pirfenidone extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  24. Cohort 3: Pirfenidone half-life in the blood (T1/2) after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  25. Cohort 3: Elimination rate constant (K[el]) for pirfenidone after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  26. Cohort 3: Apparent oral clearance (CL/F) of pirfenidone after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  27. Cohort 3: Apparent volume of distribution (Vz/F) of pirfenidone after administration alone and after coadministration with taladegib

    Time frame: Day 1 and Day 6

  28. Cohort 4: Taladegib maximum blood concentration (Cmax) after administration alone

    Time frame: Day 1

  29. Cohort 4: Time of taladegib maximum blood concentration (Tmax) after administration alone

    Time frame: Day 1

  30. Cohort 4: Taladegib absorption to time t (AUC[0-t]) after administration alone

    Time frame: Day 1

  31. Cohort 4: Taladegib total absorption (AUC[0-infinity]) after administration alone

    Time frame: Day 1

  32. Cohort 4: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone

    Time frame: Day 1

  33. Cohort 4: Taladegib half-life in the blood (T1/2) after administration alone

    Time frame: Day 1

  34. Cohort 4: Elimination rate constant (K[el]) for taladegib after administration alone

    Time frame: Day 1

  35. Cohort 4: Apparent oral clearance (CL/F) of taladegib after administration alone

    Time frame: Day 1

  36. Cohort 4: Apparent volume of distribution (Vz/F) of taladegib after administration alone

    Time frame: Day 1

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Endeavor Biomedicines, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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