Crossover study of the QT effects and PK of Mifepristone

• Research type

  Research Study

• Full title

  A Phase 1, Placebo-Controlled, Double-Blind, Randomized 2-Period Crossover Study of the QT Effects and Pharmacokinetics of a Short, Twice Daily Dosing Regimen of Orally-Administered Mifepristone Given in the Fed State to Healthy Male Subjects

• IRAS ID

  89627

• Contact name

  Muna Albayaty

• Sponsor organisation

  Corcept Therapeutics

• Eudract number

  2011-004556-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The main aim of this study is to investigate the effect of the study drug on the electrical activity of the heart (as measured by an electrocardiogram, also called an ECG). All potential new medicines must have an ECG study before they are marketed to make sure they are safe for the heart. A further aim is to look at how the study drug is taken up, metabolised (chemically broken down) and distributed through the body, how safe the study drug is and how well it is tolerated after dosing.The study will be performed at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow).This study will recruit healthy male volunteers between the ages of 18 and 45 years (inclusive). A total of approximately 20 subjects will take part in the study.Subjects' blood and urine will be tested, and vital signs measurements and other medical tests will be performed.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0156

• Date of REC Opinion

  10 Oct 2011

• REC opinion

  Further Information Favourable Opinion