Study to Investigate a New Drug in Healthy Subjects of Different Races

• Research type

  Research Study

• Full title

  A Phase 1 open-label study to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of ASP3652 in Caucasian, Japanese, Black/African and Chinese healthy male and female subjects

• IRAS ID

  109585

• Contact name

  Muna Albayaty

• Sponsor organisation

  Astellas Pharma Global Development - Europe

• Eudract number

  2012-001476-11

• Research summary

  ASP3652 is being investigated as a novel treatment for chronic pelvic pain. This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ. The study is an open-label study to assess the pharmacokinetics (how the study drug is taken up, metabolised [chemically broken down in the body], distributed through the body and excreted), pharmacodynamics (levels of biochemical markers in the bloodstream), safety and tolerability of a single dose of ASP3652 in healthy male and female subjects from Caucasian, Japanese, Black/African and Chinese origin. A total of 64 healthy male and female subjects will be included in this study (16 subjects per race group). Each race group will comprise of 8 female subjects and 8 male subjects. For each race group, plasma samples for PK and PD analysis will be collected and vital signs, safety ECG measurements, safety laboratory assessments, adverse events (AEs) and concomitant medications will be monitored throughout the entire investigational period.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0302

• Date of REC Opinion

  25 Jul 2012

• REC opinion

  Further Information Favourable Opinion