Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants who are on pirfenidone for at least 16 weeks and on a stable dose (defined as 1602-2403 mg/day) for at least 28 days at the start of Screening; the dose must be expected to remain in that range throughout the study
Documented diagnosis of IPF, per the Investigator per using the criteria of the 2011 American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Association guidelines
Participants with percent predicted forced vital capacity (FVC) more than or equal to (\>=) 50 percent (%) and percent predicted carbon monoxide diffusing capacity (DLco) \>=30% at Screening
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1% per year, during the treatment period and for at least 3 months after the final Follow-up Visit
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 4 months after the final Follow-up Visit
You may not be if
Participants with clinical evidence of active infection
Participant with any new or ongoing moderate or severe adverse reaction considered by the Investigator to be related to pirfenidone, or an pirfenidone treatment interruption in the 28 days before the start of Screening
Any condition that is likely to result in death in the 12 months after the start of Screening
Lung transplantation anticipated or any planned significant surgical intervention
Known hypersensitivity to the active substance or any excipient of either pirfenidone or nintedanib
Mild (Child Pugh A), moderate (Child Pugh B), or severe (Child Pugh C) hepatic and/or severe renal impairment
History of gastrointestinal (GI) tract perforation, unstable or deteriorating cardiac or pulmonary disease (other than IPF), long QT syndrome, alcohol or substance abuse in the 2 years before the start of screening, use of any tobacco product in the 12 weeks before the start of screening
Bleeding risk
Use of Cytochrome P450 (CYP) 1A2 (CYP1A2) inhibitors (for example, fluvoxamine, enoxacin) and/or use of inhibitors of P-glycoprotein (for example, ketoconazole, erythromycin) or CYP3A4 (for example, ketoconazole, erythromycin) or their inducers (for example, rifampicin, carbamazepine, phenytoin, St John's wort) in the 28 days before the start of Screening
Pregnancy or lactation
Hypersensitivity to peanuts and/or soy
Use of pirfenidone and/or nintedanib in a clinical study protocol in the 28 days before the start of screening
