CSF sampling after multiple doses of ASP3652 in healthy Caucasian male
Research type
Research Study
Full 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
IRAS ID
93414
Contact name
Muna Albayaty
Sponsor organisation
Astellas Pharma Europe B.V.
Eudract number
2011-004226-97
ISRCTN Number
N/A
Research summary
ASP3652 is being investigated as a treatment of chronic pelvic pain disorders. The main purpose of the study is to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ASP3652 in blood and cerebrospinaflud (CSF) samples. This means how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. In addition, the study will evaluate how well the study drug is tolerated. The study consists of a Screening Visit during which a subject??s eligibility is assessed. If eligible subjects will be admitted to the Unit on Day 1 and they will stay in the Unit for 13 days. From Day 5 to Day 9, subjects will receive study medication in the morning and in the evening. On Day 10 in the morning only. Subjects will be released from the Unit on Day 12. Subjects will return for an End of Study Visit 7 to 14 days after discharge from the Unit. PK and PD profiles of ASP3652 will be obtained on Days 1 and 10 up to 24h in CSF and up to 48h in plasma. Subjects will have a spinal tap to collect CSF on Days 1 and 2 and Days 10 and 11. A PK sample will be obtained before first dosing on Day 5. To confirm steady state concentrations in plasma, blood samples will be obtained prior to the morning dose on Days 7, 9 and 10 and prior to evening dose on Days 5, 7 and 9. Safety monitoring will occur throughout the study.
REC name
North East - York Research Ethics Committee
REC reference
12/NE/0288
Date of REC Opinion
24 Aug 2012
REC opinion
Further Information Favourable Opinion