A drug interaction study of idebenone and midazolam
Research type
Research Study
Full title
An open-label study to assess the potential for in vivo cytochrome P450 3A4 (CYP3A) inhibition and induction by idebenone in healthy male subjects using midazolam as a probe
IRAS ID
196389
Contact name
Girish Sharma
Contact email
Sponsor organisation
Santhera Pharmaceuticals
Eudract number
2015-005127-49
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
Idebenone, under the brand name of Raxone® has recently been granted marketing authorization in the European Union for the treatment of adolescents and adults with Leber’s Hereditary Optic Neuropathy (LHON). LHON leads to the degeneration of retinal ganglion cells (RGCs) and their axons that leads to an acute or subacute loss of central vision.
The purpose of this study is to investigate the effects of idebenone on an important enzyme in the body called Cytochrome P4503A (CYP3A ), as this is currently unknown. A drug called midazolam is known to be broken down in the body by the CYP3A enzyme. During the study subjects will be given midazolam alone, idebenone alone and idebenone and midazolam together. This will allow an assessment to be made on whether these enzymes continue to breakdown (metabolise) midazolam as they would normally when idebenone is present. The blood levels of idebenone after single and multiple doses will also be studied.
Volunteers will reside in the Clinical Unit at Simbec from the afternoon of Day -1 until the morning of Day 31.The study will assess the safety and blood levels of midazolam and its breakdown products, as well as the blood levels of idebenone and its breakdown products. The safety of trial participants will be monitored by qualified and appropriately trained clinical staff throughout the study, and Subjects will not be discharged from the study until they have satisfied the research physician that they are fit and well to do so.The population who are eligible to take part in the study are healthy males aged between 18 and 55 years, as identified by screening procedures at Simbec.
REC name
Wales REC 2
REC reference
15/WA/0442
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion