Safety and blood levels of repeated doses of IX-01 in healthy men
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled, parallel group, dose escalation study to investigate the safety, toleration, and pharmacokinetics of multiple oral doses of IX-01 in healthy male subjects 16-005
IRAS ID
203291
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Ixchelsis Ltd
Eudract number
2016-001310-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
IX-01 is an experimental medicine for treating premature ejaculation (PE). PE is when a man ejaculates too quickly, before or during sexual intercourse. It’s common – about 1 in 3 men experience PE during their lifetime –and can cause significant distress and relationship problems. Current treatments for PE include self-help techniques and couples’ therapy. It can also be treated with a type of antidepressant called selective serotonin reuptake inhibitors (SSRIs). Although SSRIs aren’t approved for treatment of PE, they have the useful side effect of delaying ejaculation. But, they have other unwanted side effects, and can take up to 2 weeks to work. \n\nOxytocin is a hormone that’s present in parts of the brain and some nerves. It is involved in several body functions, including sexual responses (such as arousal and ejaculation). We hope that the study medicine will delay ejaculation, by blocking the action of oxytocin. We also hope it will have fewer side effects, and work more quickly, than SSRIs.\n\nWe’ll test repeated doses of the study medicine, to find out whether there are any side effects, how much of the study medicine gets into the bloodstream, and how quickly the body gets rid of the study medicine.\n\nWe’ll give up to 24 healthy men, aged 18–45 years, 10 daily doses. We’ll start with a lower dose, and increase the dose as the study progresses. 8 of the volunteers will be randomly selected to take a placebo instead of the study medicine. \nParticipants will take up to 7 weeks to finish the study. They’ll make up to 5 outpatient visits, and stay on the ward for 11 nights.\n\nA pharmaceutical company (Ixchelsis Ltd) is funding the study.\n\nThe study will take place at 1 centre in London. \n
REC name
HSC REC B
REC reference
16/NI/0048
Date of REC Opinion
19 Apr 2016
REC opinion
Favourable Opinion