Comparison and Food Effect Study of Multiple Formulations of an IMP

• Research type

  Research Study

• Full title

  Single Dose Relative Bioavailability and Food Effect Study of Multiple Tablet Formulations of GTx-758 in Healthy Adult Male Subjects

• IRAS ID

  67018

• Contact name

  Stephen Smith

• Sponsor organisation

  Celerion on behalf of GTx, Inc.

• Eudract number

  2010-023504-27

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  To date, the Investigational Medicinal Product (IMP) being tested in this study has been given to healthy male volunteers in clinical trials as an oral (by mouth) solution. In order to move into the next stage of development/testing, a tablet formulation is being developed. The purpose of this study is to compare four possible tablet formulations of the IMP with the oral solution used in previous studies. It will also look at the effect of food on the extent to which the five formulations are absorbed into the blood stream. To investigate this, volunteers will be randomly assigned to receive a single dose of one of the five formulations on two separate occasions (i.e. two assessment periods) during the study ?? once without food and once with food. Male volunteers will take part in this study at one centre in the UK. The duration of the study from screening until the final visit could be up to 35 days (allowing for a 7 day washout interval between the two doses).

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/89

• Date of REC Opinion

  7 Dec 2010

• REC opinion

  Further Information Favourable Opinion