Relative Bioavailability of BOS172767 in Healthy Volunteers
Research type
Research Study
Full title
A Phase 1 Study to Determine the Relative Bioavailability of BOS172767 Enantiomer E1 and E2 and the Single and Repeat Dose Pharmacokinetics, Safety and Tolerability of BOS172767 Selected Enantiomer in Healthy Subjects
IRAS ID
266808
Contact name
Richard Mountfield
Contact email
Sponsor organisation
Boston Pharmaceuticals Inc.
Eudract number
2019-002289-11
Duration of Study in the UK
0 years, 6 months, 5 days
Research summary
The Sponsor is developing a new test medicine for the potential treatment of psoriasis and other auto-immune diseases. \n\nThe medicine, BOS172767, has previously been evaluated in non-clinical (animal/cell) and clinical studies as a mixture (racemate) of BOS172767-E1 and BOS172767-E2. BOS172767-E1 and BOS172767-E2 have now been separated and will be evaluated separately in this study.\n\nPart 1 of the study will look at how BOS172767-E1 and BOS172767-E2 (or placebo) are taken up and broken down by the body following a single oral dose. The safety of both BOS172767-E1 and BOS172767-E2 will also be assessed. A chosen form (E1 or E2) will then be given at increasing single oral doses, based on previous data collected in the first and second period of Part 1. This part of the study will involve 12 healthy volunteers. Each volunteer will participate in 4 study periods, each study period involving 3 overnight stays and 3 return visits to the clinical unit. Volunteers will be required to attend a follow up visit 7 to 10 days after their last dose. \n\nIn Part 2 of the study, the chosen form from Part 1 (or placebo) will be given at increasing multiple oral doses, based on previous data collected in Part 1 and Part 2. Part 2 of the study will look at how the chosen form is taken up and broken down by the body when given for 14 consecutive days. Safety will also be assessed. This part of the study will involve 3 groups of 12 healthy volunteers. Each volunteer will participate in 1 study period involving 17 overnight stays and 2 return visits to the clinical unit. Volunteers will be required to attend a follow up visit 7 to 10 days after their last dose. \n
REC name
Wales REC 2
REC reference
19/WA/0203
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion