A drug drug interaction study of INC 280 caffeine and Midazolam
Research type
Research Study
Full title
A phase 1 multicentre open label single sequence drug drug interaction study to assess the effect of INC 280 on the pharmacokinetics of midazolam and caffeine in patients with c-met dysregulated advanced solid tumours
IRAS ID
194494
Contact name
Lisa Tran
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-000813-33
Duration of Study in the UK
1 years, 3 months, 7 days
Research summary
This main purpose of this study is to test the effect of INC280 on the pharmacokinetics (PK) (i.e., how drugs are processed in the body and how the body gets rid of drugs) of 2 commonly used medications (caffeine and midazolam) in patients with cMET dyregulated advanced solid tumours.
Such studies are often referred to as drug-drug interaction¨ (DDI) studies, and the results of this study will be used to inform future patients whether it is safe for INC280 to be taken at the same time as these (or similar) drugs.
In addition this study will also look to:
Determine the side effects of INC280 how often they occur, how serious they are and how long they last
Determine whether the cancer has improved, remained stable or worsened
Approximately 32 patients will join in this study in 10 centres in US and Europe.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0022
Date of REC Opinion
6 Apr 2016
REC opinion
Further Information Favourable Opinion