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

NCT07454291 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ENV-IPF-104
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this study are to:

1. 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. 2.more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib).

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

ENV-101; taladegib; drug-drug interaction; pharmacokinetics

Outcome Measures

Primary Outcomes (36)

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

  Day 1 and Day 13

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

  Day 1 and Day 13

• 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

  Day 1 and Day 13

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

  Day 1 and Day 13

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

  Day 1 and Day 13

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

  Day 1 and Day 13

• 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.

  Day 1 and Day 13

• 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.

  Day 1 and Day 13

• 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.

  Day 1 and Day 13

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 27

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1 and Day 6

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

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

  Day 1

Study Arms (4)

Cohort 1 (effect of nintedanib on taladegib pharmacokinetics)

EXPERIMENTAL

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

Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics)

EXPERIMENTAL

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

Cohort 3 (effect of taladegib on pirfenidone pharmacokinetics)

EXPERIMENTAL

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

Cohort 4 (measure taladegib pharmacokinetics)

EXPERIMENTAL

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

Drug: taladegib

Interventions

taladegib DRUG

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

Also known as: ENV-101

Cohort 1 (effect of nintedanib on taladegib pharmacokinetics); Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics); Cohort 3 (effect of taladegib on pirfenidone pharmacokinetics); Cohort 4 (measure taladegib pharmacokinetics)

nintedanib DRUG

150 mg capsule administered twice a day

Cohort 1 (effect of nintedanib on taladegib pharmacokinetics)

pirfenidone DRUG

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

Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics)

Eligibility Criteria

• Age: 26 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endeavor Biomedicines, Inc.: lead

Study Sites (2)

Research Site

Brisbane, Queensland, 4006, Australia

RECRUITING

Research Site

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

LY2940680; nintedanib; pirfenidone

Condition Hierarchy (Ancestors)

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

Study Officials

• Lisa Lancaster, M.D.

  Endeavor Biomedicines

  STUDY DIRECTOR

Central Study Contacts

Endeavor Clinical Trials

CONTACT

1-858-727-3199; ebmclinical@endeavorbiomedicines.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)