Last reviewed · How we verify
An Open-Label, Single Oral Dose Phase I Study to Determine the Excretion Balance of Radiocarbon (i.e., the Sum of 14C-Labelled GFT505 and Its 14C-Metabolites) and to Investigate the Metabolic Profile and Pharmacokinetics of GFT505
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.
Details
| Lead sponsor | Genfit |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2014-04 |
| Completion | 2015-04 |
Conditions
- Healthy
Interventions
- 14C-labelled GFT505 120 mg
Primary outcomes
- Excretion balance of radiocarbon in whole blood, blood cells, plasma, urine, feces, and expired air after a single oral dose of 14C-labelled GFT505. — 0-19 days
Blood, urine, and feces will be collected at scheduled time intervals from before administration of the radiolabelled study drug throughout confinement at the clinical center and thereafter, if needed. Several samples of expired carbon dioxide will be obtained up to 48 h after the administration of radiolabelled study drug. Radiocarbon will be assayed in all available samples (whole blood, plasma, urine, feces, and expired air) by liquid scintillation spectrometry.
Countries
Belgium