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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05817240




Registration number
NCT05817240
Ethics application status
Date submitted
5/04/2023
Date registered
18/04/2023
Date last updated
15/12/2023

Titles & IDs
Public title
A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects
Scientific title
A Phase 1, Single-Center, Fixed Sequence, Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects
Secondary ID [1] 0 0
ENV-IPF-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - taladegib
Treatment: Drugs - nintedanib

Experimental: Experimental -


Treatment: Drugs: taladegib
100 mg per tablet, dosed once daily

Treatment: Drugs: nintedanib
100 mg per capsule, dosed once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib)
Timepoint [1] 0 0
Day 1 and Day 7
Primary outcome [2] 0 0
Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib)
Timepoint [2] 0 0
Day 1 and Day 7
Primary outcome [3] 0 0
Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib)
Timepoint [3] 0 0
Day 1 and Day 7
Primary outcome [4] 0 0
Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib)
Timepoint [4] 0 0
Day 1 and Day 7
Primary outcome [5] 0 0
Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib)
Timepoint [5] 0 0
Day 1 and Day 7

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2023
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Endeavor Biomedicines, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05817240
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Frohna, M.D., Ph.D.
Address 0 0
Endeavor Biomedicines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries