The effect of SJX-653 on blood levels of midazolam
Research type
Research Study
Full title
An open label, multiple oral dose study to evaluate the CYP3A4 mediated drug-drug interaction potential of SJX-653 in postmenopausal female subjects (HMR code: 19-002)
IRAS ID
261561
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Sojournix, Inc
Eudract number
2000-000265-20
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The study medicine (SJX-653) is an experimental new medicine for treating some of the symptoms of menopause, including hot flushes and night sweats. The menopause is when a woman stops having periods and is no longer able to get pregnant naturally, caused by a change in the balance of the body’s hormones. We think the study medicine will work by correcting the imbalance that causes hot flushes and night sweats. The study medicine is not a hormonal treatment.\n\nLike many other medicines, the study medicine is broken down in the liver by substances called enzymes. Sometimes, when you take 2 or more medicines together, it can affect how quickly enzymes break down one or both of the medicines, and how long it takes your body to get rid of them. We’re doing this study to find out if taking the study medicine together with an existing medicine (midazolam) affects the way the body handles each medicine. \n\nWe’ll recruit up to 16 healthy women, aged 40–70 years, who’ve been through the menopause or have had both of their ovaries removed. Each participant will have 1 session. They’ll take 2 oral single doses of 5 mg of midazolam on Days 1 and 12, and repeated doses of the study medicine once daily, as a tablet, on Days 3–12. \n\nParticipants will take up to 9 weeks to finish the study. They’ll have 1 stay on the ward for 14 nights, and make 1 outpatient visit.\n\nA pharmaceutical company (Sojournix, Inc) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC A
REC reference
19/NI/0072
Date of REC Opinion
15 Apr 2019
REC opinion
Further Information Favourable Opinion