Phase 1 ADME study of 14C-norUDCA in healthy males (QCL117910)
Research type
Research Study
Full title
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-norUDCA in Healthy Male Subjects
IRAS ID
229285
Contact name
Kirsten Hauswald
Contact email
Eudract number
2017-002327-15
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
The Sponsor is developing the study drug, norursodeoxycholic acid (norUDCA), for the potential treatment of primary sclerosing cholangitis (PSC). PSC is a long-term disease that slowly damages the bile ducts. Bile is a digestive liquid made in the liver that travels from the bile ducts to the gallbladder and small intestine where it helps digest fats. In patients suffering from PSC the bile ducts become blocked, causing bile to accumulate in the liver, where it gradually damages liver cells meaning the liver slowly loses its ability to function. NorUDCA is a chemical variant of a bile acid that has been shown to protect bile duct cells.\n\nThe study will try to identify how norUDCA is absorbed, broken down and removed from the body when given as a capsule. The norUDCA will be radiolabelled to analyse the study drug as it moves through the body ([14C]-norUDCA). The safety and tolerability of norUDCA will also be investigated in this study.\n\nThe study is an open-label, single dose study involving up to 6 healthy male subjects. Subjects will receive a single dose of 1500mg [14C]-norUDCA (6 × 250mg) capsules by mouth in the fasted state. Blood, urine and faeces will be collected at pre-defined time points up to a minimum of 216h post-dose (Day 10). Subjects will be discharged as a group once all subjects have met the discharge criteria. If the subjects do not meet the discharge criteria by Day 10, the subjects may remain in clinic for a maximum of up to 48h (Day 12). If the discharge criteria is still not met by Day 12, home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects.
REC name
HSC REC B
REC reference
17/NI/0138
Date of REC Opinion
12 Sep 2017
REC opinion
Further Information Favourable Opinion