Idiopathic Pulmonary FibrosisPhase 1NCT07454291
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants
A Phase 1 study testing taladegib, nintedanib and pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Endeavor Biomedicines, Inc. at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- taladegib, nintedanib and pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesAustralia
- Study dates
- 28 Apr 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 26Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Research Site
Brisbane, Queensland, 4006
Endeavor Clinical Trials, 1-858-727-3199, ebmclinical@endeavorbiomedicines.com
- Recruiting
Research Site
Melbourne, Victoria, 3004
Endeavor Clinical Trials, 1-858-727-3199, ebmclinical@endeavorbiomedicines.com
About this study
Official title: A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants
The purposes of this study are to:
- evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and
- 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- taladegib, nintedanib, pirfenidone
- Keywords
- ENV-101, taladegib, drug-drug interaction, pharmacokinetics
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taladegibDrug
Also called ENV-101
low, medium or high dose tablet administered once, or once a day
nintedanibDrug
150 mg capsule administered twice a day
pirfenidoneDrug
One, two or three 267 mg tablets administered three times a day
pirfenidoneDrug
Three 267 mg tablets administered once
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: taladegib; Drug: pirfenidone |
| Cohort 4 (measure taladegib pharmacokinetics) | Experimental | This cohort will receive a single dose of taladegib to measure its pharmacokinetic profile. Receives: Drug: taladegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Taladegib (ENV-101) maximum blood concentration (Cmax) after administration alone and after coadministration with nintedanib
Measured: Day 1 and Day 13
Cohort 1: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with nintedanib
Measured: 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
Measured: Day 1 and Day 13
Cohort 1: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with nintedanib
Measured: Day 1 and Day 13
Cohort 1: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with nintedanib
Measured: Day 1 and Day 13
Cohort 1: Taladegib half-life in the blood (T1/2) after administration alone and after coadministration with nintedanib
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 and Day 13
Cohort 2: Taladegib maximum blood concentration (Cmax) after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Taladegib absorption to time t (AUC[0-t]) after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Taladegib half-life in the blood (T1/2) after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Elimination rate constant (K[el]) for taladegib after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Apparent oral clearance (CL/F) of taladegib after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 2: Apparent volume of distribution (Vz/F) of taladegib after administration alone and after coadministration with pirfenidone
Measured: Day 1 and Day 27
Cohort 3: Pirfenidone maximum blood concentration (Cmax) after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Time of pirfenidone maximum blood concentration (Tmax) after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Pirfenidone absorption to time t (AUC[0-t]) after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Pirfenidone total absorption (AUC[0-infinity]) after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Pirfenidone extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Pirfenidone half-life in the blood (T1/2) after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Elimination rate constant (K[el]) for pirfenidone after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Apparent oral clearance (CL/F) of pirfenidone after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 3: Apparent volume of distribution (Vz/F) of pirfenidone after administration alone and after coadministration with taladegib
Measured: Day 1 and Day 6
Cohort 4: Taladegib maximum blood concentration (Cmax) after administration alone
Measured: Day 1
Cohort 4: Time of taladegib maximum blood concentration (Tmax) after administration alone
Measured: Day 1
Cohort 4: Taladegib absorption to time t (AUC[0-t]) after administration alone
Measured: Day 1
Cohort 4: Taladegib total absorption (AUC[0-infinity]) after administration alone
Measured: Day 1
Cohort 4: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone
Measured: Day 1
Cohort 4: Taladegib half-life in the blood (T1/2) after administration alone
Measured: Day 1
Cohort 4: Elimination rate constant (K[el]) for taladegib after administration alone
Measured: Day 1
Cohort 4: Apparent oral clearance (CL/F) of taladegib after administration alone
Measured: Day 1
Cohort 4: Apparent volume of distribution (Vz/F) of taladegib after administration alone
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start28 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Biomedicines, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Lancaster, M.D., Study director, Endeavor Biomedicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454291
- Sponsor's protocol ID
- ENV-IPF-104
- Status last verified
- May 2026
- First submitted
- 2 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07454291
- Acronym / sponsor ID
- ENV-IPF-104
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- ENV-101, taladegib, drug-drug interaction, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Endeavor Biomedicines, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to:
- evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (effect of nintedanib on taladegib pharmacokinetics) | Experimental | Drug: taladegib, Drug: nintedanibThis cohort will receive multiple days of nintedanib twice a day to see its effect on a single dose of taladegib. |
| Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics) | Experimental | Drug: taladegib, Drug: pirfenidoneThis cohort will receive multiple days of pirfenidone three times a day to see its effect on a single dose of taladegib. |
| Cohort 3 (effect of taladegib on pirfenidone pharmacokinetics) | Experimental | Drug: taladegib, Drug: pirfenidoneThis cohort will receive multiple days of taladegib once a day to see its effect on a single dose of pirfenidone. |
| Cohort 4 (measure taladegib pharmacokinetics) | Experimental | Drug: taladegibThis cohort will receive a single dose of taladegib to measure its pharmacokinetic profile. |
Who may qualify
- Ages
- 26 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taladegibAlso: ENV-101low, medium or high dose tablet administered once, or once a day | Drug | 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) |
| nintedanib150 mg capsule administered twice a day | Drug | Cohort 1 (effect of nintedanib on taladegib pharmacokinetics) |
| pirfenidoneOne, two or three 267 mg tablets administered three times a day | Drug | Cohort 2 (effect of pirfenidone on taladegib pharmacokinetics) |
| pirfenidoneThree 267 mg tablets administered once | Drug | Cohort 3 (effect of taladegib on pirfenidone pharmacokinetics) |
Primary outcome
Cohort 1: Taladegib (ENV-101) maximum blood concentration (Cmax) after administration alone and after coadministration with nintedanib
Time frame: Day 1 and Day 13
Cohort 1: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with nintedanib
Time frame: Day 1 and Day 13
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
Cohort 1: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with nintedanib
Time frame: Day 1 and Day 13
Cohort 1: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with nintedanib
Time frame: Day 1 and Day 13
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
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.
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.
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.
Cohort 2: Taladegib maximum blood concentration (Cmax) after administration alone and after coadministration with pirfenidone
Time frame: Day 1 and Day 27
Cohort 2: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with pirfenidone
Time frame: Day 1 and Day 27
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
Cohort 2: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with pirfenidone
Time frame: Day 1 and Day 27
Cohort 2: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with pirfenidone
Time frame: Day 1 and Day 27
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
Cohort 2: Elimination rate constant (K[el]) for taladegib after administration alone and after coadministration with pirfenidone
Time frame: Day 1 and Day 27
Cohort 2: Apparent oral clearance (CL/F) of taladegib after administration alone and after coadministration with pirfenidone
Time frame: Day 1 and Day 27
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
Cohort 3: Pirfenidone maximum blood concentration (Cmax) after administration alone and after coadministration with taladegib
Time frame: Day 1 and Day 6
Cohort 3: Time of pirfenidone maximum blood concentration (Tmax) after administration alone and after coadministration with taladegib
Time frame: Day 1 and Day 6
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
Cohort 3: Pirfenidone total absorption (AUC[0-infinity]) after administration alone and after coadministration with taladegib
Time frame: Day 1 and Day 6
Cohort 3: Pirfenidone extrapolated total absorption (AUC[extrapolated]) after administration alone and after coadministration with taladegib
Time frame: Day 1 and Day 6
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
Cohort 3: Elimination rate constant (K[el]) for pirfenidone after administration alone and after coadministration with taladegib
Time frame: Day 1 and Day 6
Cohort 3: Apparent oral clearance (CL/F) of pirfenidone after administration alone and after coadministration with taladegib
Time frame: Day 1 and Day 6
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
Cohort 4: Taladegib maximum blood concentration (Cmax) after administration alone
Time frame: Day 1
Cohort 4: Time of taladegib maximum blood concentration (Tmax) after administration alone
Time frame: Day 1
Cohort 4: Taladegib absorption to time t (AUC[0-t]) after administration alone
Time frame: Day 1
Cohort 4: Taladegib total absorption (AUC[0-infinity]) after administration alone
Time frame: Day 1
Cohort 4: Taladegib extrapolated total absorption (AUC[extrapolated]) after administration alone
Time frame: Day 1
Cohort 4: Taladegib half-life in the blood (T1/2) after administration alone
Time frame: Day 1
Cohort 4: Elimination rate constant (K[el]) for taladegib after administration alone
Time frame: Day 1
Cohort 4: Apparent oral clearance (CL/F) of taladegib after administration alone
Time frame: Day 1
Cohort 4: Apparent volume of distribution (Vz/F) of taladegib after administration alone
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Lancaster, M.D. study director
Endeavor Biomedicines
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing taladegib, nintedanib and pirfenidone in people with Idiopathic Pulmonary Fibrosis, run by Endeavor Biomedicines, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Endeavor Clinical Trials (1-858-727-3199, ebmclinical@endeavorbiomedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Taladegib (ENV-101) maximum blood concentration (Cmax) after administration alone and after coadministration with nintedanib (time frame: Day 1 and Day 13). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.