Idiopathic Pulmonary Fibrosis
Conditions
Keywords
smoothened, hedgehog, pulmonary fibrosis
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.
Interventions
DRUGtaladegib
100 mg per tablet, dosed once daily
DRUGnintedanib
100 mg per capsule, dosed once daily
Sponsors
Endeavor Biomedicines, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nintedanib maximum blood concentration (Cmax) after administration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | — |
| Time of nintedanib maximum blood concentration (Tmax) after coadministration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | — |
| Nintedanib absorption to time t (AUC0-t) after administration alone and after coadministration with ENV-101 (taladegib) | 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 |
| Nintedanib total absorption (AUC0-inf) after administration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | — |
| Nintedanib half-life in the blood (T1/2) after administration alone and after coadministration with ENV-101 (taladegib) | Day 1 and Day 7 | — |
Countries
Australia
Outcome results
None listed