A two part study to compare MED2005 against Nitrostat (Part 1) and I.V

• Research type

  Research Study

• Full title

  A single centre, open-label, randomised, single dose, six-period, reference replicate, crossover study to evaluate the bioavailability of MED2005 and Nitrostat and an extension two-period, randomised crossover study to determine the level of MED2005 remaining on the penis post application at highest concentration in healthy volunteers.

• IRAS ID

  234346

• Contact name

  Samuel Israel

• Contact email

  samuel.israel@covance.com

• Sponsor organisation

  Futura Medical Developments Ltd

• Eudract number

  2017-003396-63

• Duration of Study in the UK

  0 years, 6 months, 29 days

• Research summary

  This study is being funded by Futura Medical Development Ltd. This study is split into two parts; part 1 and 2. The purpose of Part 1 is to compare a drug called MED2005 (gel formulation of GTN) against a marketed tablet formulation called Nitrostat. The purpose of Part 2 is to compare MED2005 against marketed intravenous formulation of the same drug. To help compare the products, blood samples (part 1 and 2) and penile swabs (part 2 only) will be taken at specific times during the study after subjects have taken one of GTN formulations. Measuring drug levels in the blood will help find out how much GTN has been absorbed into the blood stream, and in penile swabs will help find out the amount of drug remaining on the glans penis.

  Fourty (40) subjects are to be enrolled with the requirement that 40 will complete the study. Some of the most important criteria are:

  - Male subjects aged between 18 and 50 and are considered to be healthy
  - Subjects are not taking any medication
  - Subjects are non-smokers or ex-smokers who haven't smoked within 4 months prior to first dose

  Part 1: The study will consist of a screening visit, 6 treatment visits (there will be at least 2 days between treatment visits), and one post study follow-up visit. Each
  treatment visit will include 1 overnight stay. The post study follow-up will
  take place 5 to 7 days after the after completion of the final treatment period.

  Part 2: The study will consist of a screening visit, 2 treatment visits (there will be at least 2 days between treatment visits), and one post study follow-up visit. Each treatment visit will include 1 overnight stay. The post study follow-up will take place 5 to 7 days after the after completion of the final treatment period.

• REC name

  Wales REC 1

• REC reference

  17/WA/0271

• Date of REC Opinion

  17 Oct 2017

• REC opinion

  Further Information Favourable Opinion