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Idiopathic Pulmonary FibrosisPhase 1NCT05817240

A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

A Phase 1 study testing taladegib and nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Endeavor Biomedicines, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
taladegib and nintedanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteAustralia
Study dates
3 May 2023to 21 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) ≥18 and ≤32 kg/m^2
  • Body weight ≤120kg
  • Subjects must be willing to be sequestered for 10 consecutive days.

Who cannot join

  • Chronic or current use of any prescription medications or acute use within the preceding 30 days or 5 half-lives, whichever is longer, with the exception of contraceptives, prior to study start
  • Subject has an active infection of hepatitis B or C, or human immunodeficiency virus (HIV) at study start
  • Subject has a 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 the screening visit, or planned participation in any such trial at time of study start
  • Subject has a pulse <45 or >100 bpm; systolic blood pressure >160 mmHg, or diastolic blood pressure >95 mmHg at study start
  • Subject has pacemaker; is not in sinus rhythm; has a corrected QT interval (QTc; using Fridericia's [QTcF] formula) of >450 ms (for males) and >470 ms (for females) during the Screening Period; or has a left bundle branch block or bifascicular block.
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  • Females and males of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 90 days after their final study dose
  • Females that are pregnant or lactating
  • Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose
  • Males who are unwilling to refrain from sperm donation for the duration of the study and for 90 days after their final study dose
  • Females who are unwilling to refrain from egg donation for the duration of the study and for 90 days after their final study dose
  • Subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101 (taladegib) or nintedanib
  • Subjects 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

1 site in 1 country.

Australia1 site

  • Research Site

    Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 1, Single-Center, Fixed Sequence, Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.

Being tested
taladegib, nintedanib
Keywords
smoothened, hedgehog, pulmonary fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, 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

    100 mg per tablet, dosed once daily

  • nintedanibDrug

    100 mg per capsule, dosed once daily

Study groups in NCT05817240
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Drug: taladegib; Drug: nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib)

    Measured: Day 1 and Day 7

  2. Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib)

    Measured: Day 1 and Day 7

  3. Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib)

    AUC 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 7

  4. Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib)

    Measured: Day 1 and Day 7

  5. Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib)

    Measured: Day 1 and Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start3 May 2023
  3. Primary completion11 Jun 2023
  4. Study completion21 Jun 2023

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05817240
Sponsor's protocol ID
ENV-IPF-102
Status last verified
Dec 2023
First submitted
5 Apr 2023
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing taladegib and nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Endeavor Biomedicines, Inc. at 1 site 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib) (time frame: Day 1 and Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05817240.

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 Dec 2023.

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