FiH, single-rising dose study with ASP7962, incl. food-effect in HVs.
Research type
Research Study
Full title
A Phase 1, Randomized, Subject- and Investigator-blinded, Sponsor-unblinded, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of ASP7962, Including a Food-effect Evaluation in Healthy Subjects
IRAS ID
140047
Contact name
Annelize Koch
Contact email
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2013-001738-16
ISRCTN Number
not provided
Research summary
The new medicine tested in this study is a compound called ASP7962. ASP7962 is being developed by Astellas Pharma for the treatment of pain associated with chronic pain conditions.
The main purpose of the study is to see how safe the study drug is and how well it is tolerated after a single dose. The study will also investigate how the study drug is taken up, metabolised (broken down in the body), 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.
This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ.
Approximately 48 healthy male and female (of non-childbaring potential) participants will be enrolled in this study. There are no specific requirements for the number of male and female (of non-childbearing potential) participants to be included in each cohort. Six (6) cohorts of 8 participants (6 participants will receive ASP7962 and 2 participants will receive matching placebo) are planned. An existing cohort of 8 participants will be used for the evaluation of the Food Effect (FE).
Safety parameters such as adverse events (AEs), electrocardiogram (ECG; routine 12-lead ECG, continuous heart activity monitoring [Holter ECG] and real-time heart activity monitoring [ECG telemetry]), vital signs (supine and standing blood pressure, pulse rate and body temperature), blood (clinical laboratory) tests (hematology, biochemistry and urinalysis), Orthostatic Challenge Tests and and Columbia –
Suicide Severity Rating Scale (CSSRS) will be collected throughout the clinical study.REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1580
Date of REC Opinion
14 Nov 2013
REC opinion
Further Information Favourable Opinion