Pharmacokinetic Study of the Effect of Food and Age on an IMP
Research type
Research Study
Full title
An investigation of the pharmacokinetic profile including the effects of food and age of four prototype formulations of ONO-8539 and the current formulation in healthy young male adult and healthy elderly male subjects in a three-part study using an open-label randomised cross-over design
IRAS ID
31192
Contact name
Johnston Stewart
Contact email
Sponsor organisation
Ono Pharmaceutical Co., Ltd.
Eudract number
2009-013225-42
Research summary
This study involves a new medication that has been developed as a treatment for overactive bladder (OAB). It works in the body in a different way to current treatments and may offer effectiveness in treating OAB with fewer of the unpleasant side effects.
The current formulation of this new medication is an immediate-release tablet. Results from clinical trials using this formulation indicate that the amount of the new medication absorbed into the body is low in relation to the dose given and is affected by food and age; it is removed from the body quickly; and there is a lot of variability in results between volunteers.
The purpose of this study is to compare 4 prototype formulations (an improved solubility formulation and 3 different sustained-release formulations) of the new medication with the current formulation with the aim of finding the one that best improves the way that the new medication gets into and is handled by the body.
Volunteers in Part A (12 healthy young males) will complete 3 treatment periods, during which the 3 new sustained-release formulations will be given under fed conditions in a random order. One (1) of these formulations will be selected for further testing in Parts B and C.
Volunteers in Part B (12 healthy young males) will complete 5 treatment periods, during which the current formulation will be given under fed conditions and the improved solubility formulation and the formulation selected from Part A will be given under fed and fasted conditions in a random order.
Volunteers in Part C (12 healthy elderly males) will complete 2 treatment periods, during which the improved solubility formulation and the formulation selected from Part A will be given under fed conditions in a random order.
Each dose will be separated by an interval of at least 7 days.
The maximum duration of the study from screening until the Follow-up Visit (if performed 7 days after leaving the clinic in the final period) could be up to 46 days (Part A) / 60 days (Part B) / 39 days (Part C) for each volunteer.
REC name
Scotland A REC
REC reference
09/IEC02/20
Date of REC Opinion
16 Oct 2009
REC opinion
Further Information Favourable Opinion