The effect of food on SJX-653 in postmenopausal women v1
Research type
Research Study
Full title
An open label, randomized, single dose, 2- period, crossover study to evaluate the pharmacokinetics, safety and tolerability of SJX-653 with and without food in postmenopausal women
IRAS ID
261560
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Sojournix, Inc
Eudract number
2019-000264-25
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (SJX-653) is an experimental treatment for 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\nWe’ll test the study medicine in up to 12 healthy women, aged 40–70 years, who’ve been through the menopause (are ‘post-menopausal’). We aim to test whether food affects the blood levels of a tablet form of the study medicine. We’ll compare blood levels of the tablet with a capsule form of the study medicine. We also aim to find out the side effects and blood levels of the tablet form of the study medicine.\n\nEach participant will have 3 study sessions. They’ll be given a single dose of the study medicine, by mouth, in each study session. Participants will take the tablet form in 2 of the study sessions (once with and once without food) and the capsule form (without food) in the other study session.\n\nParticipants will take up to 11 weeks to finish the study. They’ll stay on the ward for 9 nights in total (3 nights in a row per study session), and have 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/0071
Date of REC Opinion
16 Apr 2019
REC opinion
Further Information Favourable Opinion