Scintigraphy Study to Assess Rectal Brilacidin (QSC205066)
Research type
Research Study
Full title
A Phase I, Single Period, Open-Label, Scintigraphic Study to Evaluate the In Vivo Performance of a Rectal Enema Formulation of Brilacidin in Healthy Volunteers
IRAS ID
297327
Contact name
Giulia Bruno
Contact email
Sponsor organisation
Alfasigma S.p.A
Eudract number
2020-005932-31
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
The Sponsor is developing the test medicine, Brilacidin, for the potential treatment of inflammatory bowel conditions such as ulcerative proctitis and ulcerative proctosigmoiditis. The conditions are both forms of ulcerative colitis, a long-term condition where the colon and rectum become inflamed. The test medicine has anti-bacterial and anti-inflammatory properties that should help reduce the symptoms of these conditions. The test medicine will be administered in the form of an enema, which is a liquid medicine given via the rectum (back passage).\n\nThe test medicine recipe is radiolabelled, which means that the test medicine has a radioactive component. When taking images with a specialised camera, this allows us to see how the test medicine moves through the rectum and colon and assess the performance of the test medicine. The study will also try to evaluate the pharmacokinetic profile of the test medicine (how the test medicine is taken up by the body). Safety and tolerability will be assessed. \n\nThis is a single period study, involving up to eight healthy male and female volunteers (of non-childbearing potential). Volunteers will receive a single 200 mg dose of the test medicine on one occasion. Following dosing, images will be taken of the lower abdominal regions, at regular intervals from immediately after dosing until six hours post-dose. Volunteers will be discharged from the clinical unit at 48 hours-post dose and will receive a follow-up phone call three to five days after discharge, to ensure their continued wellbeing. \n
REC name
HSC REC A
REC reference
21/NI/0070
Date of REC Opinion
18 May 2021
REC opinion
Further Information Favourable Opinion