Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of
drug that is recovered over time via different elimination routes of the body, i.e., whole
blood, blood cells, plasma, urine, feces, and expired air. The ideal case is to be able to
demonstrate a (near) complete recovery (≥95 %) of the administered dose.
A good understanding of the metabolic pathway of the study drug is equally important.
Mass-balance data, together with metabolic profiles in excreta, are used to characterize the
biotransformation pathways of a drug and to help evaluate its drug-drug interaction
potential.
To this purpose, in this study, blood, urine, and feces are collected to investigate the
metabolic profile of GFT505, and plasma and urine are collected to investigate the
non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other
metabolites will be investigated in plasma and urine according to the radioactivity results.
Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated
according to the radioactivity results.
Phase:
Phase 1
Details
Lead Sponsor:
Genfit
Collaborators:
SGS Life Sciences SGS Life Sciences, a division of SGS Belgium NV