A Safety, Tolerability, PK and DDI Study of ASP6432 in Healthy Males

• Research type

  Research Study

• Full title

  A 3-part study to investigate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of ASP6432 in healthy male subjects; including investigation of any food effect and investigation of the effect of ASP6432 on the CYP3A4 substrate midazolam

• IRAS ID

  106846

• Contact name

  John Lambert

• Sponsor organisation

  Astellas Pharma Global Development - Europe

• Eudract number

  2012-000548-87

• Research summary

  The new medicine tested in this study is a compound called ASP6432. The compound is being developped for treating lower urinary tract symptoms associated with benign prostatic hyperplasia (a noncancerous enlargement of the prostate gland, makes urination difficult and uncomfortable). The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted, how this process is possibly altered by food by giving the study drug in the presence and absence of meals and to look at the effect of the study drug on the cytochrome P450 (CYP) 3A4 substrate midazolam and its metabolite. Midazolam may be used as an intravenous sedative before and during minor medical, dental and surgical procedures. The study will be performed at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow). Approximately 132 participants will be included in the study (approximately 72 in Part 1, 12 in Part 2 and 48 in Part 3). Participants will receive the study drug or placebo in the form of tablets which they will swallow with a glass (240 mL) of water. Participants will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations and electrocardiograms (ECGs) will be performed, height and weight will be measured, blood pressure, pulse rate and body temperature measurements will be taken, different kinds of urine and blood safety tests will be performed, blood samples for measurement of the concentration of study drug, any adverse events that participants experience and other medication they take, will be recorded.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  12/EE/0255

• Date of REC Opinion

  13 Jul 2012

• REC opinion

  Further Information Favourable Opinion