A 2-period study to evaluate Roginolisib (IOA-244) in healthy volunteers
Research type
Research Study
Full title
A Randomised, Open-label, Two-period, Parallel Group Design, Phase I Study to Assess the Effect of Food, Pharmacokinetics and Pharmacodynamics of Roginolisib (IOA-244) in Healthy Subjects
IRAS ID
1008779
Contact name
Gabrielle Brill
Contact email
Sponsor organisation
iOnctura SA
ISRCTN Number
ISRCTN11462643
Research summary
Research Summary
The purpose of this study is to investigate IOA-244 (also known as roginolisib). The main objectives 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.
- To evaluate the effect of IOA-244 on the body (known as pharmacodynamics) by analysing the levels of specific biomarkers in the body (markers within the body such as a gene, molecule or characteristic which can be used to identify the presence of a particular biological process occurring in the body or a particular disease).
- 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.
- To determine the safety and tolerability (degree to which side effects of the study drug can be tolerated) of IOA-244 when it is administered
at two different dose strengths and following administration in a fasted state (without food) and fed state (following a high-fat, high-calorie meal).The study will consist of up to 32 participants with each participant required to complete both treatment periods. Across the two treatment periods, each participant will receive:
- a single dose of IOA-244 (40 or 80 milligrams (mg)) in the form of oral capsules in a fasted state,
- a single dose of IOA-244 (40 or 80 mg) in the form of oral capsules following a high-fat, high-calorie meal.Each dose in each treatment period will be separated by a period of at least 6 days. Blood, urine and stool samples will be taken in order to measure the levels of IOA-244 and specific markers associated with the study drug. We will analyse the results from each of the treatment periods and combine this information in order to better understand how IOA-244 works in the body.
Summary of Results
"The purpose of this study was to investigate the study drug IOA-244 (also known as roginolisib). The main objectives of the study were as follows:
To investigate the effect of food on the levels 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.
To evaluate the effect of IOA-244 on the body (known as pharmacodynamics) by analysing the levels of specific biomarkers in the body (markers within the body such as a gene, molecule or characteristic which can be used to identify the presence of a particular biological process occurring in the body or a particular disease).
To investigate the levels of IOA-244 in the blood, how this changed over a period of time and to measure if and how the levels differed when IOA-244 was administered at two different dose strengths.
To determine the safety and tolerability (degree to which side effects of the study drug can be tolerated) of IOA-244 when it was administered at two different dose strengths and following administration in a fasted state (without food) and fed state (following a high-fat, high-calorie meal).
As well as evaluating the above, the study also evaluated, as exploratory objectives, the levels of IOA-244 in the urine and faeces (stool) and measured the levels of specific markers associated with the study drug and its’ effect on the body. The purpose of the study was to evaluate the study objectives described above when IOA-244 was given as a single dose at two different dose strengths and in the presence and absence of food across two treatment periods. The study consisted of up to 32 participants with each participant required to complete both treatment periods.
Across the two treatment periods, each participant received:
a single dose of IOA-244 (40 or 80 milligrams (mg)) in the form of oral capsules in a fasted state,
a single dose of IOA-244 (40 or 80 mg) in the form of oral capsules following a high-fat, high-calorie meal.
Each dose in each treatment period was separated by a period of at least 6 days. Blood, urine and stool samples were taken at set timepoints throughout the study in order to measure the levels of IOA-244 and to measure for specific markers associated with the study drug. The results from each of the treatment periods have been analysed and combined in order to better understand how IOA-244 works in the body following assessment of different factors within each treatment period i.e., different dose strengths and the effect of the presence/absence of food.
With respect to the safety objectives of the study, it was determined that both doses of IOA-244 (40 mg and 80 mg) were considered to be safe and well tolerated following administrations in both a fed and fasted state. A total of 9 adverse events were reported by 6 participants across the study reported with all events classified as mild or moderate in severity and not related to the study drug.
As it relates to the other objectives of the study, the following results were reported:
Following single-doses of 40 mg and 80 mg IOA-244 in fed and fasted state, it was determined that food did delay the rate at which the study drug was absorbed; however, there was no impact on the amount of the study drug which was absorbed.
Following a single dose of 40 mg or 80 mg IOA-244 in both the fed and fasted states, there were no food or dose-related safety changes/trends observed.
Across both the 40 mg and 80 mg dose levels, the levels of the study drug found in urine were shown to be approximately 24% - 27% whilst the levels observed in faeces was low at approximately < 0.5%.
In summary, the data gathered during the study were considered sufficient to meet the objectives of the study."
REC name
Wales REC 1
REC reference
24/WA/0151
Date of REC Opinion
2 Aug 2024
REC opinion
Further Information Favourable Opinion