Safety and blood levels after different forms of RhuDex; v2
Research type
Research Study
Full title
Comparative pharmacokinetics of different formulations of RhuDex and subsequent evaluation of safety, tolerability and PK of ascending multiple doses of the lead formulation of RhuDex in healthy volunteers (HMR code: 16-032)
IRAS ID
231433
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Dr Falk Pharma GmbH
Eudract number
2017-001348-37
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine is an experimental treatment for primary biliary cirrhosis (PBC), a rare disease of the liver. PBC is caused by the body’s immune system attacking the ‘bile ducts’, which carry digestive fluid (‘bile’) from the liver to the digestive tract. That causes a build-up of bile, which damages the liver. \n\nThe study medicine works by preventing the immune system attacking the bile ducts. We hope that it’ll work better, and have fewer side effects, than existing treatments for PBC. \n\nWe’ll do this study in 2 Parts.\n\nIn Part A, we’ll compare blood levels after 4 forms of the study medicine: a liquid, 1 or 2 capsules and 1 tablet. We’ll give 16 healthy men, aged 18–55 years, a single dose of 25 mg on 4 occasions. Participants will take up to 8 weeks to finish the study. They’ll have 4 study sessions of 3 nights (12 nights overall) and make 10 outpatient visits.\n\nIn Part B, we’ll test repeated doses of one form of study medicine from Part A, to find out its blood levels, its effects on the body and any important side effects. We’ll study 3 groups of 16 healthy people, aged 18–55 years (36 participants overall). Each participant will receive a single dose followed by 7 daily doses. We’ll start with a low dose, and increase the dose as the study progresses. In each group, 4 participants will receive dummy medicine instead of study medicine. Participants will take up to 7 weeks to finish the study. They’ll stay on the ward for 1 study session of 16 nights, and make 2 outpatient visits.\n\nA pharmaceutical company (Dr Falk Pharma GmbH) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
17/NI/0136
Date of REC Opinion
25 Sep 2017
REC opinion
Further Information Favourable Opinion