Safety, Tolerability and PK of ASP7713 in Healthy Volunteers
Research type
Research Study
Full title
A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP7713 in Healthy Adult and Elderly Subjects
IRAS ID
221224
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Astellas Pharma Europe BV (APEB)
Eudract number
2016-004845-10
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
This is a single-site, two-part, randomised, blinded, placebo-controlled clinical trial to assess the safety, tolerability and pharmacokinetics (PK) following single and repeated ascending doses of orally administered ASP7713 under fasted conditions, in healthy adult subjects (Parts 1 and 2) and healthy elderly subjects (Part 2 only). Conditional inclusion of women of childbearing and of non-childbearing potential is allowed in this study. Both study parts will include a screening visit, an investigational period and an end-of-study visit. During the investigational periods, eligible subjects will be residential at the clinical unit for 5 days/4 nights (Part 1), or 18 days/17 nights (Part 2).
The main purpose of the study is to see how safe the study drug is and how well the body tolerates the study drug after single and repeated doses, administered orally to healthy adult and elderly subjects. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) in healthy subjects (referred to as PK).
This is the first time ASP7713 is administered in humans. ASP7713 is being developed for the treatment of underactive bladder (UAB). The study drug is an orally, dosed, small molecule with inhibitory activity on the phosphodiesterase (PDE) 9 enzyme. As novel inhibitor for PDE9, ASP7713 has a potential to improve voiding dysfunction by urethral relaxation during the voiding phase.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0156
Date of REC Opinion
18 May 2017
REC opinion
Further Information Favourable Opinion