Study 35406

If you are a healthy male aged between 18 and 50, then you may be eligible to participate in a study investigating a new drug being developed for a range of different diseases associated with fibrosis, including Crohn’s Disease.

*Terms & Conditions apply.

Study Information

Simbec-Orion Clinical Pharmacology will soon be running a three-part study to investigate the study drug, RXC008.

The overall objectives of this study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and concentration in the blood, urine, tissue and stool of RXC008 when RXC008 is administered in different conditions i.e., single versus multiple doses, evaluating different dose strengths and the effects of administration in the presence and absence of food. Blood, urine, tissue and stool samples will be taken at set timepoints throughout each part of the study in order to measure the levels of RXC008. In the context of the whole study, we will analyse the results from each of the groups and each study part and combine this information in order to better understand how RXC008 works in the body following assessment of different factors within each study part i.e., single versus multiple doses, different dose strengths and the effects of administration in the presence and absence of food (if conducted).

RXC008 is being developed for the treatment of a condition called fibrosis as a result of Crohn’s Disease. Fibrosis is a condition where tissues in the body scar and stiffen causing permanent damage, and in the case of Crohn’s Disease (which is an inflammatory condition that can lead to fibrosis of the bowel), the affected tissues are the bowel and large intestine. Currently, there are limited treatment options available for this condition which are considered long term and effective and therefore, there is an unmet need to develop potential new treatments which could be more effective.

This study will be split into three separate parts (Part A, Part B and Part C), and you will only participate in one part of the study (Part A and Part B for healthy volunteers only).

Part A

The purpose of Part A is to evaluate the study objectives when RXC008 is administered as a single dose at increasing dose strengths.

In addition, one group in Part A may investigate the effect of food on RXC008 by taking a single dose of RXC008 following an overnight fast and then following a high fat meal. This evaluation is considered to be optional and will only be conducted if deemed necessary to do so. Part A will consist of up to 6 planned groups of up to 6 participants (with the option to include a maximum of 2 additional groups of up to 6 participants): each group will evaluate a different dose of RXC008 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 RXC008 or a placebo (which contains no active drug) in the form of an oral capsule(s). If you participate in this part of the study and are in the non-food effect groups (or choose not to participate in the food effect evaluation if your group is selected for this evaluation) i.e., only completing one treatment period, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) followed by a post study follow-up visit approximately 14 days following the dose of RXC008 on Day 1.

If you participate in this part of the study and are in the food effect group i.e., completing two treatment periods, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) per treatment period followed by a follow-up visit approximately 14 days following the last dose on Day 1 of treatment period 2. Each dose in each treatment period will be separated by a period of a few weeks; however this period may be longer so you will be informed during the course of the study as to whether you are participating in this group and in addition, when you will need to return to complete the second treatment period.

Regardless of which group you are participating in, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study.

If you are in the non-food effect groups (or choose not the participate in the food effect evaluation if your group is selected for this evaluation) i.e., only completing one treatment period and you complete this part of the study, you will receive a maximum inconvenience payment of £1750. If you are in the food effect group i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3200.

For all groups in Part A, you will be required to stay at the clinical unit for a maximum of 4 overnight stays per treatment period and if you are invited to complete the second treatment period for evaluation of food effect, then the gap between the two doses in each treatment period will be a few weeks in duration. You will be informed as to whether your study group has been selected for this evaluation requiring completion of the second treatment period and therefore how long the study will be for you (including providing details of when you will need to return to complete the second treatment period as applicable).

In addition, the current planned treatment period for all groups in Part A is up to a maximum of 4 overnight stays for each treatment period i.e., from Day -1 to Day 4. However, it is possible that following review of the data generated from each group in Part A that the length of the treatment period may be reduced by one day and therefore, the treatment period will only last from Day -1 to Day 3 (only 3 overnight stays). You will be told as to whether this change is applicable to your group but should ensure that you are available to complete the 4 overnight stays before agreeing to participate in the study. In addition, you should ensure that you are available to complete all required visits before agreeing to participate in the study.

If you are in the non-food effect groups (or choose not the participate in the food effect evaluation if your group is selected for this evaluation) i.e., only completing one treatment period and you complete this part of the study, you will receive a maximum inconvenience payment of £1750.

If you are in the food effect group i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3200.

Study Payment: £1750 to £3200 Apply. Be amazing

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