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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05817240
• Other study ID #: ENV-IPF-102
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2023
• Est. completion date: June 21, 2023

Study information

• Verified date: December 2023
• Source: Endeavor Biomedicines, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 21, 2023
• Est. primary completion date: June 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• taladegib
100 mg per tablet, dosed once daily
• nintedanib
100 mg per capsule, dosed once daily

Locations

Country	Name	City	State
Australia	Research Site	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Endeavor Biomedicines, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib)		Day 1 and Day 7
Primary	Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib)		Day 1 and Day 7
Primary	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	Day 1 and Day 7
Primary	Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib)		Day 1 and Day 7
Primary	Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib)		Day 1 and Day 7