A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants

Prior treatment

• 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.
• Current alcohol or drug abuse.
• Smoking or other nicotine use (including but not limited to vaping, nicotine patch, nicotine gum or nicotine lozenge) within 3 months prior to screening, current smoker, or unwillingness to refrain from smoking for the duration of the study.
• 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 screening, during screening, or planned participation in any such trial while participating in this study.
• Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to screening, or planned during the course of the trial.
• Participants with clinically significant cardiac abnormalities including but not limited to: has pacemaker; or is not in sinus rhythm during screening; or has a left bundle branch block or bifascicular block during screening; or any prior history of ventricular arrhythmia or torsades de pointes.

Other illness

• Active infection with hepatitis B or C, or human immunodeficiency virus (HIV) during screening.
• History or presence (per participant history) of:
  • Autoimmune disease such as rheumatoid arthritis or systemic lupus erythematosus
  • Thrombophlebitis or deep vein thrombosis
  • Hematologic or coagulation disorders
  • Liver disease or dysfunction; Gilbert's syndrome
  • Renal dysfunction or glomerulonephritis
  • Coronary artery disease
  • Diverticular disease
  • Congestive heart failure or ventricular dysfunction
  • Clinically significant cardiovascular, gastrointestinal, pulmonary, endocrine, central nervous system disorders, or other major active and uncontrolled disease in the opinion of the Investigator.
• 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.
• Participants with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of taladegib (all cohorts), nintedanib (Cohort 1), or pirfenidone (Cohorts 2 and 3).

Other

• Participant is unwilling to adhere to the on-study diet provided by the clinical site during study participation.
• Females who are pregnant or nursing.
• Participants that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of any study treatment.
• Males who are unwilling to refrain from sperm donation for the duration of the study and for 95 days after their final dose of any study treatment.
• Females who are unwilling to refrain from egg donation for the duration of the study and for 95 days after their final dose of any study treatment.
• Participants 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.

• 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.
• Participants are willing to remain on study treatment for the duration of the study and comply with all study days and procedures.
• Participants willing to sign and have a full understanding of the informed consent.
• Participants must be willing to be sequestered for the time period indicated for their respective cohort.