Absolute Bioavailability of UPA in Healthy Females (QBR114878)

• Research type

  Research Study

• Full title

  A Study of the Absolute Oral Bioavailability of Ulipristal Acetate in Healthy Female Subjects

• IRAS ID

  126467

• Contact name

  Stuart Mair

• Sponsor organisation

  HRA Pharma

• Eudract number

  2013-000592-32

• Research summary

  The purpose of the study is to assess how the study drug ulipristal acetate is absorbed by the body (absolute bioavailability of UPA and PK parameters) when given as a single oral dose and when given as a radiolabelled dose intravenously (injected into a vein).‘Radiolabelled’ means that the test drug has a radioactive component which helps us to track where the drug is in the body.Ulipristal acetate given by mouth is currently marketed in Europe and the USA, as ellaOne® (Europe) or ella® (US), for emergency contraception (after unprotected sexual intercourse or contraception failure) and in Europe for the treatment of uterine fibroids (non-cancerous tumours in the womb) as esmya®. This will be the first time that the study drug has been given by injection into a vein.The safety and tolerability of the drug will also be assessed.In this study 6 healthy female subjects will receive a single 30mg dose of study drug by mouth, followed by a 30 µg dose of study drug into a vein which contains a radioactive component.

• REC name

  HSC REC B

• REC reference

  13/NI/0042

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Further Information Favourable Opinion