Safety, Tolerability and PK of TOP1288 in Healthy Volunteers
Research type
Research Study
Full title
A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOP1288 ORAL SINGLE ASCENDING AND MULTIPLE DOSES IN HEALTHY VOLUNTEERS
IRAS ID
216958
Contact name
Muna Albayaty
Contact email
Sponsor organisation
TopiVert Pharma Ltd
Eudract number
2016-004065-46
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 5 days
Research summary
This is a phase 1, randomized, double-blind, placebo-controlled study in healthy volunteers, looking at the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered TOP1288.
TOP1288 is being developed by TopiVert Pharma for the treatment of ulcerative colitis (UC). UC is a long term condition where the lining of the colon and rectum (bowel) become inflamed. Tiny ulcers develop on the surface of the lining which may bleed and produce pus. The main symptoms are recurring diarrhea which may contain blood, abnormal abdominal pain, tiredness, fatigue and generally feeling unwell.
This is not the first time TOP1288 has been administered. TOP1288 has been previously administered via rectal formulation in the first-in-human study (TV-01) to 44 healthy volunteers and 5 patients with UC. The main purpose of this study is to see how safe orally administered TOP1288 is and how well the body tolerates the drug after single and multiple doses. This is the first time that TOP1288 Oral will be administered. The study will investigate the pharmacokinetics of oral TOP1288. Finally, the study will also look at the concentration of the study drug and biomarkers in samples of tissue taken from the bowel.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1911
Date of REC Opinion
4 Jan 2017
REC opinion
Further Information Favourable Opinion