The purposes of this study are to:
1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and 2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib).
This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.
Participants are reproductively sterile.
Body Mass Index (BMI) ≥ 18.5 and ≤ 32 kg/m2 and body weight ≥ 50 kg at study start.
Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or electrocardiograms (ECGs) prior to dosing, as deemed by the Investigator.
Able to swallow multiple capsules and tablets.
Chronic or current use of any prescription or over the counter medications; or acute use of prescription medications within 14 days or 5 half-lives, whichever is longer, or over the counter medications within 7 days or 5 half-lives, whichever is longer, prior to study start, or planned use during all study periods.
Participant is unwilling to refrain from fruits (including juices) that inhibit CYP3A4, including grapefruit, Seville orange, pomelo, or star fruit, beginning 7 days prior to study start through end of study.
Active infection with hepatitis B or C, or human immunodeficiency virus (HIV) during screening.
Current alcohol or drug abuse.
Single group
taladegib
Druglow, medium or high dose tablet administered once, or once a day
nintedanib
Drug150 mg capsule administered twice a day
pirfenidone
DrugOne, two or three 267 mg tablets administered three times a day
pirfenidone
DrugThree 267 mg tablets administered once
Cohort 1: Taladegib (ENV-101) maximum blood concentration (Cmax) after administration alone and after coadministration with nintedanib
Cohort 1: Time of taladegib maximum blood concentration (Tmax) after administration alone and after coadministration with nintedanib
Cohort 1: Taladegib absorption to time t (AUC[0-t]) after administration alone and after coadministration with nintedanib
AUC\[0-t\] 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
Cohort 1: Taladegib total absorption (AUC[0-infinity]) after administration alone and after coadministration with nintedanib
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