Safety, Tolerability & PK of SAD, MAD & FE ASP2205 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1 Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of ASP2205
IRAS ID
164201
Contact name
Annelize Koch
Contact email
Sponsor organisation
Astellas Pharma Europe BV (APEB)
Eudract number
2014-003059-71
Duration of Study in the UK
0 years, 8 months, 14 days
Research summary
This first in human study, is divided into 2 parts. 104 subjects are planned to participate in this study, this may however be increased to 132 subjects.
Part 1 will involve healthy young males and females (aged 25 to 55 years, inclusive).
Part 2 will involve healthy young (aged 25 to 55 years, inclusive) and elderly (aged = 65 years) females.
The new medicine tested in this study is a compound called ASP2205. It is hoped that ASP2205 will be helpful in treating patients with stress urinary incontinence. Stress incontinence occurs when your bladder leaks urine during physical activity or exertion.
The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals. The study will also try to understand why men and women respond differently to the same drug through DNA testing.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Central nervous system safety monitoring will be done with the use of questionnaires. Blood and urine samples for pharmacokinetic analysis and metabolic profiling will be collected. Blood samples will be collected for future pharmacogenetic analysis.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1691
Date of REC Opinion
19 Nov 2014
REC opinion
Further Information Favourable Opinion