Safety, Tolerability, PK and PD study of ASP6282 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6282 in Healthy Nonelderly and Elderly Male and Female Subjects, Including a Food Effect Cohort and Drug-drug Interaction Cohort with Itraconazole
IRAS ID
176876
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Astellas Pharma Europe BV (APEB)
Eudract number
2015-000093-35
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
The sponsor is developing ASP6282 for treating underactive bladder.
The study is divided into 3 parts. A maximum of 160 healthy subjects will be included in the study.
Part 1 is a SAD study that includes Food Effect and Drug-drug Interaction with Itraconazole. The purpose of part 1 is:
•To see how safe the study drug is and how well it is tolerated after dosing.
•To investigate how the safety and tolerability of the study drug is possibly affected by food, by giving the study drug in the presence and absence of meals.
•To investigate how the study drug is taken up, metabolised, distributed through the body and excreted.
•To investigate what affects the study drug has on the body.
•To look at how the pharmacokinetics is possibly altered by food by giving the study drug in the presence and absence of meals.
•To see how safe the study drug is and how well it is tolerated after being given with a drug called itraconazole.
•To see if the drug itraconazole, affects the pharmacokinetics of the study drug.Part 2 is a MAD study. The purpose of part 2 is:
•To see how safe the study drug is and how well it is tolerated after dosing.
•To investigate how the study drug is taken up, metabolised, distributed through the body and excreted.
•To investigate what affects the study drug has on the body.Part 3 is a Proof of Pharmacology study. The purpose of part 3 is:
•To investigate what affects the study drug has on pilocarpine-induced salivation and in your pupil diameter.
•To investigate how the safety and tolerability of the study drug when given in combination with pilocarpine.
•To investigate how the study drug and pilocarpine are taken up, metabolised, distributed through the body and excreted.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0119
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion