A drug drug interaction study between ACT-539313 & Midazolam
Research type
Research Study
Full title
A single-center, open-label study to investigate the effect of a single oral dose and repeated oral doses of ACT-539313 on the pharmacokinetics of midazolam and its metabolite 1-hydroxymidazolam in healthy male subjects.
IRAS ID
233619
Contact name
Annelize Koch
Contact email
Sponsor organisation
Idorsia Pharmaeuticals Ltd
Eudract number
2017-002844-33
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
The drug being investigated in this study is called ID-082, which is a drug that is proposed to help with the treatment of anxiety and related conditions. It was administered in a drug-drug interaction study together with non-therapeutic doses of midazolam. Midazolam, a drug prescribed for anxiety and to help with sleeping problems, has been marketed for many years and is frequently used in studies of this kind.\n\nIn this study, midazolam was administered alone as well as simultaneously with the test drug (ID-082) on differing days of the study. The collection of blood samples at various time-points over the course of the study enables us to observe the interaction between ID-082 and midazolam. This will be accomplished through measuring concentrations of the parent compound (midazolam) and its main degradation product (1-hydroxymidazolam) in order to detect any possible changes in metabolic activity, i.e., changes in blood levels of midazolam and 1-hydroxymidazolam, which might have occurred due to the co-administration with ID-082.\n\nTwenty subjects were included and completed the study as planned.\n
REC name
Wales REC 2
REC reference
17/WA/0277
Date of REC Opinion
16 Sep 2017
REC opinion
Favourable Opinion