Single and repeated doses of SJX-653 in postmenopausal women
Research type
Research Study
Full title
A phase I, randomised, placebo-controlled, double-blind, single and repeated dose study to assess the safety, tolerability, and pharmacokinetics of SJX-653 in postmenopausal female subjects (18-009) \n
IRAS ID
250643
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Sojournix, Inc
Eudract number
2018-002316-27
Duration of Study in the UK
1 years, 0 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 hope 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 56 healthy women who’ve been through the menopause (post-menopausal), aged 40–70 years. We aim to find out its side effects, blood levels and effects on the levels of certain hormones. We’ll start with a small dose, and increase the dose as the study progresses. \n\nThe study is in 2 parts: \n \n* Part A: up to 8 participants, in 1 group, will each have a single dose of study medicine. They’ll take up to 7 weeks to finish the study, stay on the ward for 4 nights in a row, and make 1 outpatient visit. \n* Part B: up to 48 participants, in 4 groups of 8 – 12, will have repeated doses of study medicine. They’ll take up to 9 weeks to finish the study, stay on the ward for 13 nights in a row, and make 1 outpatient visit. \n\nA pharmaceutical company (Sojournix, Inc) is funding the study. \n\nThe study will take place at 2 centres: 1 centre in London and 1 centre in Belfast. \n\nWord count: 252/300\n
REC name
HSC REC B
REC reference
18/NI/0144
Date of REC Opinion
14 Sep 2018
REC opinion
Favourable Opinion