Safety, Tolerability and PK of MAD of ASP7962 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Oral Multiple Doses of ASP7962 in Healthy Male and Female Subjects
IRAS ID
153241
Contact name
Annelize Koch
Contact email
Sponsor organisation
Astellas Pharma Europe BV
Eudract number
2014-000159-95
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The new medicine tested in this study is a compound called ASP7962. It is hoped that ASP7962 will be useful as a treatment for osteoarthritis pain and chronic low back pain.
This study will recruit healthy males and females (of non-childbearing potential) between the ages of 18 and 55 years, inclusive. The length of study participation is expected to be approximately 7 weeks. The study will take place at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Harrow, UK.
The primary objective of this study is to investigate the safety and tolerability of ASP7962 when given as multiple doses in healthy subjects. The study will also investigate how ASP7962 is absorbed, distributed, metabolized and eliminated by the body when given as multiple doses in healthy subjects.
Clinical safety assessments will be done throughout the study. The safety and tolerability of multiple doses of ASP7962 will be assessed by:
• Adverse events
• Vital signs (blood pressure, pulse rate, body temperature)
• Clinical laboratory tests (hematology, biochemistry, urinalysis)
• Electrocardiograms (routine 12-lead ECG, continuous cardiac monitoring [Holter ECG] and real-time cardiac monitoring [ECG telemetry])
• Orthostatic challenge tests (test to see how posture changes influence blood pressure)
• Cognitive testing (CogState cognitive test battery: Groton Maze Learning Task, Groton Maze Learning Task–Delayed Recall, Detection Task, Identification Task, One Card Learning Task and One Back Task)
• Questionnaires (Columbia–Suicide Severity Rating Scale, Bond and Lader Visual analogue scale and Addiction Research Center Inventory).Pharmacokinetic analysis will be done to determine the amount of ASP7962 in the body:
• Blood samples will be collected for metabolic profiling (a method used to analyse how the body metabolises the study medication).
• Urine samples will be collected to measure the amount of the study medication that is excreted from the body at various time points and also for metabolic profiling.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0119
Date of REC Opinion
7 May 2014
REC opinion
Further Information Favourable Opinion