Healthy Subjects Clinical Trial
Official title:
A Phase I, Open-label Study to Investigate the Safety, Tolerability and Plasma and Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ASP3652 in Healthy Young Caucasian Male Subjects
The purpose of this study is to evaluate the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of multiple doses of ASP3652 in healthy young Caucasian male subjects. Also to evaluate the plasma and CSF pharmacodynamics (PD) of multiple doses of ASP3652 in healthy young Caucasian male subjects and to assess the safety and tolerability of multiple doses of ASP3652 in healthy young Caucasian male subjects.
Screening takes place between Day -22 to Day -2. Subjects are admitted to the clinical on
Day -1 and remain until Day 12.
On Days 5 to 9, subjects receive twice-daily doses of ASP3652, and a single dose on the
morning of Day 10. Subjects fast for 10h before the morning dose on Days 5 to 9 and they are
served the first standard meal 1h after the morning dose.
A spinal tap is used to collect cerebrospinal fluid (CSF) on Day 1 and Day 10. A plasma
sample for PK sample is obtained before first dosing on Day 5. To confirm steady-state
concentrations of ASP3652 in plasma, blood samples are obtained before the morning dose on
Days 7, 9 and 10, and before the evening dose on Days 5, 7 and 9. On Day 10, a PK profile of
ASP3652 in plasma is obtained for up to 48h after the morning dose and for up to 24h in CSF.
Profiles of several enzyme substrates in plasma and seminal fluid (exploratory) are obtained
on Day 1 and Day 10 up to 24h in CSF and up to 48h in plasma, before the morning and evening
dose on Days 5, 7 and 9 in plasma.
Vital signs, 12-lead electrocardiograms (ECGs), safety laboratory assessments, adverse
events (AEs) and concomitant medication are monitored throughout the investigational period
until the ESV.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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