DISCOVER A NEW WAY TO HELP
If you are a healthy male aged between 18 and 64, then you may be eligible to participate in a study investigating a new drug being developed for the potential treatment of premature ejaculation.
Study Payment £1275
CLINICAL TRIAL information
Simbec-Orion Clinical Pharmacology will soon be running a five-part study to investigate a drug called KH-001.
The overall objectives of the study are to determine the safety, tolerability and concentration in the blood and urine of the study drug when evaluated in different conditions i.e., different dose strengths, following administration of single and multiple doses, administration in the presence and absence of food and administration of the drug in different forms.
The study also aims to evaluate the effect of the study drug on the body, particularly assessing the effect of the drug on overall mood state.
We will analyse the results from each of the study groups/parts and combine this information in order to better understand how KH-001 works in the body following assessment of different factors within each study part i.e., single and multiple doses, different dose strengths, different dose forms, in the presence and absence of food and comparing between a plant-based (botanical) and man-made (synthetic) version of the drug.
KH-001 is being developed as a potential treatment for a condition known as premature ejaculation (a condition characterised by ejaculation within 1-2 minutes of initiating sexual intercourse).
Currently, there are limited treatment options available for this condition with
treatments often associated with side effects. Therefore, there is an unmet
need to develop more effective treatments that can be used long-term with
reduced side effects.
This study will be split into five separate parts, and you will only participate in
one part of the study (with the exception of participants in Groups 1-3 of Part
A who may be invited to also take part in Part C).
WE ARE CURRENTLY RECRUITING PART A ONLY.
The purpose of Part A is to evaluate the study objectives when KH-001 is given as a single dose on one occasion at different dose strengths.
Part A will consist of 4 planned groups of up to 8 participants (with the option to include a maximum of 2 additional groups with up to 8 participants each).
Each group will evaluate a different dose of KH-001 starting at the lowest dose and gradually increasing in each group. This is known as a single ascending dose (SAD) study.
Each group will receive KH-001 or a placebo (which contains no active drug) in the form of an oral liquid which participants will swallow.
If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a period of 3 days (2 overnight stays – Day -1 to Day 2) for the treatment period, followed by a post-study follow-up visit 5-7 days following the last dose of KH-001.
You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study.
You should also note that the timing of the post-study follow up visit may be extended from 5-7 days post-dose if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place).
If you complete this part of the study, you will receive a maximum inconvenience payment of £1275, plus travel expenses.
CLINICAL TRIAL timeline
Part A Study Dates
You will only take part in one group within Part A of the study; however, if you participate in Groups 1-3 of Part A, you may also be eligible to participate in Part C (Food Effect). If this is the case, and you wish to participate in Part C, you will be required to complete, sign and date a new participant information sheet and consent form which is specific to Part C at the time you participate.
Cohort 1: FULLY BOOKED
Cohort 2: FULLY BOOKED
Screening From: 9th January
Into Simbec: 5th February
Leave Simbec: 7th February
Follow-Up Visit: 12th February
Screening between: 11th January
Into Simbec: 7th February
Leave Simbec: 9th February
Follow-Up Visit: 13th February
If you complete Part A of this study, you will receive a maximum inconvenience payment of £1275.
We additionally pay travel expenses up to a maximum of £50 per journey required to Simbec.
Thank you for your time to register your interest in this trial please complete the below form.
OR to speak to a member of the Enrolment Team for more information or regarding any questions or queries please ring 0800 691995 and please select option 1. Alternatively drop us an email: email@example.com