A drug-drug interaction study of ASP3652

• Research type

  Research Study

• Full title

  An open label, drug-drug interaction study to assess the effect of multiple doses of gemfibrozil on the single dose pharmacokinetics of ASP3652 and to assess the effect of multiple doses of ASP3652 on the single dose pharmacokinetics of repaglinide

• IRAS ID

  92985

• Contact name

  Muna Albayaty

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2011-002874-21

• ISRCTN Number

  not known

• Research summary

  ASP3652 is being investigated as a novel treatment for chronic pelvic pain. The main purpose of the study is to investigate the effect of multiple doses of gemfibrozil on the pharmacokinetics (how the study drug is taken up, metabolised [chemically broken down in the body], distributed through the body and excreted) of a single dose of ASP3652 (in Part 1), and the effect of multiple doses of ASP3652 on the pharmacokinetics of a single dose of repaglinide (in Part 2). This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. The study is divided into 2 parts, including 20 subjects each, with an open-label, one-sequence crossover design. Subjects participating in Part 1 are not allowed to participate in Part 2. In Part 1, the effect of multiple doses of gemfibrozil twice daily (12 hours interval) on the PK of a single oral dose of ASP3652 will be evaluated. In Part 2, the effect of multiple doses of ASP3652 twice daily (12hour interval) on the PK of a single oral dose of repaglinide will be evaluated. Blood samples will be collected and safety monitored throughout the investigational period. An End of Study Visit (ESV) will be performed 7-14 days after discharge or early discharge.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0384

• Date of REC Opinion

  5 Apr 2012

• REC opinion

  Further Information Favourable Opinion