Phase 1 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are permanently unable to have children (reproductively sterile)
• People with a body mass index (BMI) between 18.5 and 32, and who weigh at least 50 kg at the start of the study
• People who are generally in good health, with no significant medical concerns found during health checks, physical exams, blood tests, or heart tracings (ECGs), as determined by the study doctor
• People who are able to swallow multiple capsules and tablets
• People who are willing to stay on the study treatment for the full duration of the study and attend all required visits and follow all study procedures
• People who are willing to read, understand, and sign an informed consent form
• People who are willing to stay at the study site (be sequestered) for the required period for their assigned group

Who may not be able to join:

• People who regularly take, or have recently taken, any prescription or over-the-counter medicines (prescription medicines within the last 14 days or longer, and over-the-counter medicines within the last 7 days or longer, or who plan to take any during the study)
• People who are unwilling to avoid certain fruits — including grapefruit, Seville oranges, pomelo, and star fruit (and their juices) — starting 7 days before the study begins and throughout the entire study
• People who have an active hepatitis B, hepatitis C, or HIV infection at the time of screening
• People who currently misuse alcohol or drugs
• People who have smoked or used nicotine products (including vaping, patches, gum, or lozenges) in the 3 months before screening, who currently smoke, or who are unwilling to avoid smoking for the full duration of the study
• People who have a history of, or currently have, any of the following conditions: autoimmune diseases (such as rheumatoid arthritis or lupus); blood clots or deep vein thrombosis; blood or clotting disorders; liver disease or a condition called Gilbert's syndrome; kidney problems or kidney inflammation; coronary artery disease; diverticular disease (a bowel condition); heart failure or reduced heart function; or significant heart, digestive, lung, hormone, or nervous system disorders, as determined by the study doctor
• People who have had any type of cancer in the last 5 years, except for certain cervical cancers treated in place or non-melanoma skin cancers that were fully removed by surgery
• People who have taken part in another clinical trial involving an experimental treatment within the last 30 days or longer, or who plan to join another trial while in this study
• People who have had major surgery requiring a hospital stay within 3 months before screening, or who have planned surgery during the trial
• People with significant heart rhythm or electrical problems, including having a pacemaker, an irregular heart rhythm, certain types of heart conduction abnormalities, or a history of serious irregular heartbeats (confirm with trial site)
• People who are unwilling to eat only the diet provided by the clinical site during the study
• People who are pregnant or currently breastfeeding
• People who are unwilling to avoid donating blood or blood products during the study and for 30 days after their last dose of study treatment
• Males who are unwilling to avoid donating sperm during the study and for 95 days after their last dose of study treatment
• Females who are unwilling to avoid donating eggs during the study and for 95 days after their last dose of study treatment
• People who have had a severe allergic reaction or known sensitivity to any ingredient in the study drugs — taladegib (all groups), nintedanib (Group 1), or pirfenidone (Groups 2 and 3)
• People who are immediate family members (such as a spouse, parent, child, or sibling) of staff directly involved in running the trial or working for the trial sponsor

Important: Always verify eligibility with the trial site directly before applying.