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If you are a healthy male aged between 18 and 55, then you may be eligible to participate in a clinical trial investigating a treatment being developed for a range of different diseases associated with fibrosis and inflammation.
Various inconvenience payments ranging from £1625 to £2650.
Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called RXC007.
RXC007 is being developed for the treatment of a range of different diseases associated with fibrosis and inflammation. RXC007 is specifically being developed to treat a condition called idiopathic pulmonary fibrosis (IPF) but may also be utilised in the treatment of non-alcoholic steatohepatitis (NASH), liver and kidney disease.
Currently, there are limited treatment options available for this condition (IPF) which are considered long term and effective and therefore, there is an unmet need to develop potential new treatments which could be more effective.
The main objectives of this study are as follows:
- To determine the safety and tolerability of RXC007 when it is administered as single and multiple doses at different dose strengths over a period of up to 14 days.
- To investigate the concentration of RXC007 in the blood, how this changes over a period of time and to evaluate whether there are differences in the concentration between different dose strengths over time and between single or multiple doses.
- To investigate the effect of food on the concentration of RXC007 in the blood and to investigate if there any effects/interactions between RXC007 and 2 other drugs (rosuvastatin and metformin).
Part A will consist of 6 planned groups of 6 participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group. In addition, one group in Part A will investigate the effect of food on the safety, tolerability and concentration of RXC007 in the blood by taking a single dose of RXC007 following an overnight fast and then following a high fat breakfast.
If you are in the non-food effect groups, 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 and you should therefore ensure that you are able to commit to completing this.
If you are in the food effect group, 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 with approximately 4 weeks gap between the two treatment periods. Each treatment period is followed by a follow-up visit and you should therefore ensure that you are able to commit to completing this.
Note: 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).
If you are in the non-food effect groups and you complete this part of the study, you will receive a maximum inconvenience payment of £1625. If you are in the food effect group and you complete this part of the study, you will receive a maximum inconvenience payment of £2650.
Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.