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RecruitingNCT07454291Updated May 15, 2026

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

A Phase 1 interventional study of taladegib and nintedanib in Idiopathic Pulmonary Fibrosis, sponsored by Endeavor Biomedicines, Inc.. Recruiting at 2 sites in Australia. Open to participants aged 26 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Endeavor Biomedicines, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
26 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • ENV-101
  • taladegib
  • drug-drug interaction
  • pharmacokinetics
03

In context

Idiopathic Pulmonary Fibrosis

551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's planned enrollment of 57 is close to the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Endeavor Biomedicines, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (estimated)

Study arms

  • Experimental
    Cohort 1 (effect of nintedanib on taladegib pharmacokinetics)

    This cohort will receive multiple days of nintedanib twice a day to see its effect on a single dose of taladegib.

    Drug: taladegib · Drug: nintedanib

  • Experimental
    Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics)

    This cohort will receive multiple days of pirfenidone three times a day to see its effect on a single dose of taladegib.

    Drug: taladegib · Drug: pirfenidone

  • Experimental
    Cohort 3 (effect of taladegib on pirfenidone pharmacokinetics)

    This cohort will receive multiple days of taladegib once a day to see its effect on a single dose of pirfenidone.

    Drug: taladegib · Drug: pirfenidone

  • Experimental
    Cohort 4 (measure taladegib pharmacokinetics)

    This cohort will receive a single dose of taladegib to measure its pharmacokinetic profile.

    Drug: taladegib

Interventions

  • Drugtaladegib

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

    Also known as: ENV-101

  • Drugnintedanib

    150 mg capsule administered twice a day

  • Drugpirfenidone

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

  • Drugpirfenidone

    Three 267 mg tablets administered once

06

What researchers measure

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

    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

    Time frame: Day 1 and Day 13

  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

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

    Time frame: Day 1 and Day 13

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

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

    Time frame: Day 1 and Day 13

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

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

    Time frame: Day 1 and Day 13

  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

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07454291
Lead sponsor
Endeavor Biomedicines, Inc.
Responsible party
Sponsor
First posted
Mar 6, 2026
Start date
Apr 28, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
May 15, 2026

Study contacts

Endeavor Clinical Trials
Contact
ebmclinical@endeavorbiomedicines.com
1-858-727-3199
Lisa Lancaster, M.D.
study director · Endeavor Biomedicines

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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