DDI Study with Itraconazole and Lu AF11167
Research type
Research Study
Full title
Interventional, open-label, interaction study investigating the effects of itraconazole (inhibitor of CYP3A4/5) on the pharmacokinetics and safety of Lu AF11167 in healthy young subjects
IRAS ID
156850
Contact name
Ashley Brooks
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2013-003870-28
Research summary
The metabolic breakdown of Lu AF11167 is mainly performed by a sub-set of the liver enzymes family called CYP450. The functioning of some of these enzymes can be inhibited by other medicines and also some food items such as grapefruit. When the breakdown of Lu AF11167 is inhibited, it is expected that the exposure to the body may be both higher and of longer duration than would otherwise be the case.
The studies conducted with Lu AF11167 so far have not given rise to safety concerns. However, Lu AF11167 has been found to cause side effects. The side effects are dose dependent and their severity limits how much medicine a subject can tolerate.
Therefore, it is important to test the effect of liver enzyme inhibition on the breakdown of this drug to measure if and how much the concentration of the drug increases. This will help generate an understanding of which dose of Lu AF11167 should be given to patients.
One medicine which inhibits some of the liver enzymes is the anti-fungal medication itraconazole which is to be used in the current study.
Healthy people will be given Lu AF11167 at a low dose, in order to minimise any risk associated with inhibiting breakdown. People will be given Lu AF11167 on two occasions, first on its own, and secondly after a few days of itraconazole medication. In addition to this, a few people with a natural limitation in their liver enzyme capacity will be evaluated on an exploratory basis.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/0304
Date of REC Opinion
18 Jun 2014
REC opinion
Further Information Favourable Opinion