TOP1288 RECTAL SINGLE AND MULTIPLE ASCENDING DOSES
Research type
Research Study
Full title
A PHASE 1 STUDY TO EVALUATE THE SAFETY/TOLERABILITY AND PHARMACOKINECTICS OF TOP1288 RECTAL SINGLE AND MULTIPLE ASCENDING DOSES IN HEALTHY SUBJECTS AND MULTIPLE DOSES IN SUBJECTS WITH ULCERATIVE COLITIS
IRAS ID
173758
Contact name
James Ritter
Contact email
Sponsor organisation
Topivert Pharma Ltd
Eudract number
2014-004374-41
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
TOP1288, a narrow spectrum protein kinase inhibitor, is being developed as a novel, non absorbed treatment for ulcerative colitis (UC). UC is a disease of unknown cause characterised by inflammation of the lining of the large intestine and manifesting with abdominal pain and bloody diarrhoea. TOP1288 given rectally has a local anti-inflammatory action in experimental models of UC. The present study will be the first time TOP1288 has been given to humans and explores the safety, tolerability and how the body handles (absorbs, distributes and eliminates)this drug and seeks evidence of the biochemical effect of the drug in the body. To eliminate bias subjects are randomly allocated (as in tossing a coin) to active TOP1288 or placebo (dummy drug), and investigators and study subjects do not know which treatment they receive (the trial is “double-blind”). The study is in three parts: Part 1 investigates single doses in up to 5 groups of 6 healthy volunteers, each group dosed with an increased dose provided the drug was safe and well tolerated at the previous level. Part 2 investigates multiple ascending doses in up to 4 groups of 9 healthy volunteers. Part 3 investigates one dose level by administering that dose each day in 1 group of 8 patient volunteers with UC. The study design is adaptive – that is after the first dose level in part 1, which is predefined, the exact dose and dose-intervals can be modified from a pre-set plan by a safety review committee in the light of the emerging results.
Each subject will have 3 visits:
A screening visit with informed consent and clinical assessment of potential eligibility.
A residential period at Quintiles Research Unit with rectal drug administration and assessments of safety, tolerability, drug distribution and action.
A follow up visit: –Approximately 7 days after the last drug administration.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0383
Date of REC Opinion
10 Apr 2015
REC opinion
Further Information Favourable Opinion