1199.229 Drug-drug interaction study with nintedanib and pirfenidone
Research type
Research Study
Full title
Investigation of drug-drug interaction between nintedanib and pirfenidone in patients with IPF (an open label, multiple-dose, two group study followed by nintedanib open label treatment)
IRAS ID
187068
Contact name
Sophie Fletcher
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2015-000732-15
Duration of Study in the UK
1 years, 3 months, 17 days
Research summary
This research study will be conducted in 50 Idiopathic Pulmonary Fibrosis patients at 7 sites in the UK.
Patients who are not currently being treated with pirfenidone or nintedanib will go into Group 1 and patients who are currently being treated with pirfenidone will go into Group 2. Group 1 patients will be treated in the PK part of the trial for 24 days and Group 2 patients will be treated in the PK part of the trial for 16 days. All PK sampling will take place on two separate days during the PK part of the trial.
All patients will then have 28 days where they do not take any trial medication. They will then go on to the open label nintedanib part of the trial where they will receive nintedanib for 6 months. Additional testing will include routine safety procedures, such as safety laboratory testing, physical examinations, spirometry, ECGs and vital signs.
The study is of importance to the overall development of IPF treatment. It will help Investigators to understand the effect and safety of giving patients both pirfenidone and nintedanib in combination to treat IPF in the future.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1500
Date of REC Opinion
20 Nov 2015
REC opinion
Further Information Favourable Opinion