Study of BIIB091 MR Formulations in Healthy Subjects (QSC202693)

• Research type

  Research Study

• Full title

  An Open-Label, Pharmacokinetic Study to Evaluate the Pharmacokinetics and Relative Bioavailability of BIIB091 Modified Release Formulations and to Assess the Impact of Food, a Proton Pump Inhibitor and CYP3A4 Inhibitor on BIIB091 Exposure using the Selected Formulation in Healthy Subjects

• IRAS ID

  279510

• Contact name

  Mike Palte

• Contact email

  mike.palte@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2020-000682-16

• Duration of Study in the UK

  0 years, 5 months, 24 days

• Research summary

  Summary of Research
  The Sponsor is developing a new test medicine to treat active forms of multiple sclerosis (MS). MS is a condition that can affect the brain and spinal cord causing a wide range of potential symptoms, including problems with vision, limb movement, sensation/ balance. It is a lifelong condition that can sometimes cause serious disability.

  The study will consist of up to three parts and will involve up to 44 healthy male and (non-lactating) female volunteers. The study aims to identify a suitable formulation (recipe) of the test medicine by assessing the pharmacokinetics (what the body does to the drug) in the fed and fasted states as both single and multiple doses. The safety, tolerability and the effect of Rabeprazole (medicine that decreases stomach acid secretion) and Intraconazole (slows breakdown of the drug) has on the test medicine may also be investigated.

  Part 1 consists of up to 5 study periods involving single dose administrations of the test medicine formulations in the fasted state. Part 2 (optional) is split into Cohort A (up to 3 periods) and B (up to 2 periods) and will test the selected recipe from Part 1. In Cohort A periods 1 and 2, volunteers will receive single doses of the test medicine (fed and fasted) and in period 3 will receive multiple doses of Rabeprazole followed by the test medicine formulation. In Cohort B period 1, volunteers will receive a single dose of the test medicine formulation (fasted) and in period 2 will receive multiple doses of Intraconazole followed by the test medicine formulation. Part 3 (optional) has one study period involving multiple doses of test medicine formulation for up to 10 days.

  For each part, a follow-up phone call will take place 7-10 days post-final dose to ensure the wellbeing of volunteers.

  Summary of Results
  The plain language summary of study results will be uploaded to the following location:
  https://scanmail.trustwave.com/?c=261&d=gPOB5SI0t7cHg_-hXp9tiI5w_FkPs-WMZvevjnCpag&u=https%3a%2f%2fu2790089%2ect%2esendgrid%2enet%2fls%2fclick%3fupn%3dXv3JSvJ-2B3M71ppf7N9agbbOMfES2mUsGkz5jfFv7TpqWmO7b4KLEOHo9YgBI6ca7-2Fl9LpEC-2BN2c0CVfVqrkWnrOeesFCDNysvM6RQXyGCSV3iSY-2BzKjMC9iCaHsajNazp6B3ODeOLayGzOLhsUesFg-3D-3DKsxW%5fE1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLPS-2FvOkuSiFNwnphLs8wL1cwXkC6D7LHAAttMrjpbEzzwaWdelQYmAQ-2F5qcH-2FfAB5Lkd1eF0dajJJAJwqcGA1mKQFqllf6M9wSIzbGI6UnIDEZ1SXNXz-2F6UrxUa5kphSCD-2F70NKeWKDwWqAXnf0kXWYrREzOFi9l-2FeSbHIj-2FNozw-3D-3D
  The results summary is anticipated to be live on this site by the end of the month.

• REC name

  Wales REC 2

• REC reference

  20/WA/0223

• Date of REC Opinion

  15 Sep 2020

• REC opinion

  Further Information Favourable Opinion