A drug drug interaction study of ceritinib with warfarin and midazolam
Research type
Research Study
Full title
A phase I, multi-centre, open label, drug-drug interaction study to assess the effect of ceritinib on the pharmacokinetics of warfarin and midazolam administered as a two-drug cocktail in patients with ALK-positive advanced tumours including non-small cell lung cancer (NSCLC)
IRAS ID
198971
Contact name
Clement Dubos
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2014-003741-95
Duration of Study in the UK
5 years, 4 months, 27 days
Research summary
The main purpose of this study is to test the effect of ceritinib on the pharmacokinetics (i.e., how drugs are processed in the body and how the body gets rid of drugs) of 2 commonly used medications (midazolam and warfarin) in patients with ALK+ advanced solid tumours.
These studies are often referred to as “drug-drug interaction” studies, and the results of this study will be used to inform future patients whether it is safe for ceritinib to be taken at the same as these (or similar) drugs.
In addition, the study will also determine the side effects of oral ceritinib - how often they occur, how serious they are, and how long they last. Tumour assessments will determine whether the disease has improved, remained stable, or worsened.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0140
Date of REC Opinion
8 Apr 2016
REC opinion
Further Information Favourable Opinion