- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05817240
A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects
December 14, 2023 updated by: Endeavor Biomedicines, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Endeavor Clinical Trials
- Phone Number: 1-858-727-3199
- Email: ebmclinical@endeavorbiomedicines.com
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5000
- Research Site
-
Contact:
- Endeavor Clinical Trials
- Phone Number: 1-858-727-3199
- Email: ebmclinical@endeavorbiomedicines.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Body Mass Index (BMI) ≥18 and ≤32 kg/m^2
- Body weight ≤120kg
- Subjects must be willing to be sequestered for 10 consecutive days.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
|
100 mg per tablet, dosed once daily
Other Names:
100 mg per capsule, dosed once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib)
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
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Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib)
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
|
Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib)
Time Frame: Day 1 and Day 7
|
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
|
Day 1 and Day 7
|
Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib)
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
|
Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib)
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paul Frohna, M.D., Ph.D., Endeavor Biomedicines
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2023
Primary Completion (Actual)
June 11, 2023
Study Completion (Actual)
June 21, 2023
Study Registration Dates
First Submitted
April 5, 2023
First Submitted That Met QC Criteria
April 5, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
December 15, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENV-IPF-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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