If you are a healthy volunteer aged 18+, then you may be eligible to participate in a study investigating a new drug being developed for potential treatment for different types of cancer, including cancers involving the blood and cancers which result in the formation of tumours.
Study Payment* £5300
*Terms & Conditions apply.
Study Information
Simbec-Orion Clinical Pharmacology is running a study to investigate the study drug, IOA-244 (also known as roginolisib).
IOA-244 is being developed as a potential treatment for different types of cancer, including cancers involving the blood (e.g., leukaemia and lymphoma) and cancers which result in the formation of tumours classified as solid tumours (e.g., breast and lung cancer).
Currently, there are various different treatments available for these types of cancer; however these are often associated with side effects and cause widespread effect/damage on the non-cancerous cells and tissue in the body.
Therefore, there is an unmet need to develop more effective treatments that can actually specifically only target the cancer cells, and which have reduced overall side effects.
The main objectives of the study are as follows:
To investigate the effect of food on the concentration of IOA-244 in the blood following administration of IOA-244 in both a fasted state (without food) and fed state (following a high-fat, high-calorie meal) at two different dose strengths. Also to determine the safety and tolerability of IOA-244 when it is administered in a fasted state and fed state.
As well as evaluating the above, we will also investigate, as exploratory objectives, the levels of IOA-244 in the urine and faeces (stool) and measure the levels of specific markers associated with the study drug and its’ effect on the body.
To evaluate the effect of IOA-244 on the body (known as pharmacodynamics) by analysing the levels of specific biomarkers in the body. Also to investigate the concentration of IOA-244 in the blood, how this changes over a period of time and to measure if and how this concentration differs when IOA-244 is administered at two different dose strengths.
Study Timeline
The purpose of the study is to evaluate the study objectives described above when IOA-244 is given as a single dose at two different dose strengths and in the presence and absence of food across two treatment periods. The study will consist of up to 32 participants with each participant required to complete both treatment periods.
Screening Visit
(Day -35 to Day -2)
Treatment Period 1 & 2
(Day -1 to Day 6 per treatment period*)
Post-Study Follow Up Visit
(6-10 days following last dose)
