Bioavailability of [14C]-AQX-1125 in Healthy Subjects (QCL117583)
Research type
Research Study
Full title
An Open-Label, 2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structure for [14C]-AQX-1125 in Healthy Subjects
IRAS ID
210753
Contact name
David A Green
Contact email
Sponsor organisation
Aquinox Pharmaceuticals Inc.
Eudract number
2016-002703-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
The Sponsor is developing the study drug, AQX-1125, for the potential treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) also known as "painful bladder syndrome" which causes long term bladder pain and the need to urinate often. As the disease progresses, the pain can become so severe that it affects the patient's quality of life, often requiring frequent use of pain killers. AQX-1125, acting to reduce inflammation, may be better at treating the pain caused by IC/BPS and reducing abnormally frequent urination than currently available treatments.
The study will use radiolabelled doses of AQX-1125 to identify how the study drug is taken up, absorbed and removed by the body. The safety and tolerability of the drug will also be assessed.The study will consist of 2 parts involving up to 8 healthy male and female subjects. In Part 1, up to 8 subjects will receive a single dose of 200 mg study drug given as 2 tablets to swallow. Subjects will then receive a single radiolabelled dose of the study drug given as a long, slow injection. In Part 2, subjects will be given a single radiolabelled dose of 200 mg AQX-1125 as a solution to swallow.
REC name
Wales REC 1
REC reference
16/WA/0297
Date of REC Opinion
1 Nov 2016
REC opinion
Further Information Favourable Opinion