Colonic Delivery of Brilacidin Dose Escalation Study

• Research type

  Research Study

• Full title

  A Phase 1, Single Dose Escalation Study to Investigate the Use of Delayed Release Tablets for Colonic Delivery of Brilacidin in Healthy Volunteers

• IRAS ID

  271799

• Contact name

  Howard N.E. Stevens

• Contact email

  howard.stevens@bddpharma.com

• Sponsor organisation

  Innovation Pharmaceuticals Inc.

• Eudract number

  2019-003367-22

• Duration of Study in the UK

  0 years, 1 months, 3 days

• Research summary

  In this study two prototype OralogiK delayed release tablets containing the drug Brilacidin will be investigated.
  
  This is single centre, randomised, single blind, placebo-controlled, single dose escalation study in 9 subjects. Each subject will receive one treatment at one assessment visit. Subjects will be dosed at a 2:1 ratio in three cohorts, each consisting of three subjects:

  Cohort 1: 50mg Brilacidin or Placebo
  Cohort 2: 100mg Brilacidin or Placebo
  Cohort 3: 200mg Brilacidin (2 x 100mg tablets) or Placebo

  A radiolabel containing technetium-99mn(99m-Tc) will be added to each tablet to allow sequential scintigraphic images to be taken using a gamma camera following dosing. In cohorts 1 and 2 each tablet – including placebo – will be radiolabelled to contain 4 MBq 99mTc at time of dosing. In cohort 3 each tablet will be radiolabelled with 2MBq 99mTc to give a total dose of 4MBq.

  Blood samples will be drawn to allow measurement of drug levels in the bloodstream. Vital sign measurements will be taken at pre-defined timepoints to monitor subject's blood pressure and heart rate.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  19/LO/1554

• Date of REC Opinion

  4 Nov 2019

• REC opinion

  Further Information Favourable Opinion