Safety, Tolerability, PK and PD of ASP3700 as MAD in healthy subjects
Research type
Research Study
Full title
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of ASP3700 in Healthy Subjects.
IRAS ID
164659
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Astellas Pharma Europe BV
Eudract number
2014-003226-41
Duration of Study in the UK
0 years, 6 months, days
Research summary
The new medicine tested in this study is a compound called ASP3700 (referred to as the “study drug” throughout the remainder of this document). Astellas Pharma BV is developing the study drug for treating pain that is associated with osteoarthritis. Cartilage cushions bones at the joints and keeps the bones from rubbing against each other. Osteoarthritis occurs when this cartilage wears away. The loss of cartilage results in pain, reduced range of motion, and swelling.
This study will recruit healthy, non-smoking, males and females between the ages of 18 and 55 years. A total of 36 subjects will take part in the study. Additional subjects, up to a maximum of 24 subjects, may be enrolled in the study should additional doses be needed or additional dose groups be added.
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 the body responds to the study drug.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood and urine samples for pharmacokinetic.
analysis will be collected.REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/1738
Date of REC Opinion
21 Oct 2014
REC opinion
Further Information Favourable Opinion