Status:
COMPLETED
A Study to Assess the Safety, Tolerability and Effects of Single Ascending Doses of ASP3652 in Healthy Subjects
Lead Sponsor:
Astellas Pharma Europe B.V.
Conditions:
Pharmacokinetics
Pharmacodynamics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to explore the safety (including the effect on cardiac intervals), tolerability, the effects on the Central Nervous System (CNS), as well as the CNS side effect profile of...
Detailed Description
Each subject receives 3 single ascending doses of ASP3652 and a single dose of matching placebo during one randomly selected investigational period. Randomization is conducted separately for males and...
Eligibility Criteria
Inclusion
- Subject is white and of Caucasian origin.
- Body Mass Index more than or equal to 18.5 and less than 30.0kg/m2.
- Male subject must agree to practice an adequate contraceptive method with female sexual partners to prevent pregnancy.
- Female subject must agree to practice an adequate contraceptive method with male sexual partners to prevent pregnancy.
Exclusion
- Pregnancy within 6 months before screening assessment or breast feeding within 3 months before screening (for females subjects only).
- Known or suspected hypersensitivity to ASP3652, or any components of the formulation used.
- A mean QTc(F) interval of \>430 ms (for males) and \>450 ms (for females) after triplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). In case of an abnormal QTc(F) interval, the assessment may be repeated once (in triplicate). If the QTc(F) interval exceeds the limits, two additional Electrocardiogram (ECG)s can be recorded and the average of the three QTc(F) values should be used to determine the subject's eligibility.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01815684
Start Date
August 1 2012
End Date
December 1 2012
Last Update
March 21 2013
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333CL