PK study of BOS172767 formulations in healthy subjects (QCL118174)
Research type
Research Study
Full title
A Phase 1 Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, PPI Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
IRAS ID
236053
Contact name
Ashley Milton
Contact email
Sponsor organisation
Boston Pharmaceuticals Inc.
Eudract number
2017-004002-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 4 days
Research summary
The Sponsor is developing the study drug, BOS172767, for the potential treatment of psoriasis and other autoimmune diseases. The immune system is your body's defence against disease and infection, but in psoriasis patients, it attacks healthy skin cells by mistake.
This trial will look at how different formulations (recipes) of BOS172767 are taken up by the body, and the effect of food and a medicine that decreases stomach acid on the study drug.
This study will consist of up to 3 parts. Part 1 will enrol up to 12 subjects, that will attend the clinic 6 times to receive Regimens A-F. Subjects will receive either a new BOS172767 prototype formulation or BOS172767 reference capsule formulation. Part 2 is an increasing dose study in 10 subjects that will attend the clinical unit up to 4 times to receive Regimens G-J. Subjects will receive either a selected BOS172767 prototype or Regimen J (optional) may be a dose of BOS172767 prototype with a medicine that decreases stomach acid (Proton Pump Inhibitor). The dose will be increased per regimen. Part 3 is a multiple increasing dose study, with 3 cohorts of 12 subjects, who will be randomised to receive either a BOS172767 prototype or matching placebo for 14 days; with the dose increasing per cohort.
Each study period in Parts 1 and 2 will follow the same study design. Subjects will be dosed on Day 1 and be discharged on Day 3. There will be a minimum washout of 5 days between each product administration. Subjects will attend a follow-up visit 7-10 days after their final dose. In Part 3, Subjects will be dosed on Day 1-14 and will remain on site until Day 17. Subjects will attend a return visit on Days 18 and 19, and then attend a follow-up visit 7-10 days after their last dose.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0013
Date of REC Opinion
7 Feb 2018
REC opinion
Further Information Favourable Opinion