Healthy Clinical Trial
Official title:
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.
This is a Phase I open-label, single oral dose and single center study of 14C-labelled
GFT505 and its metabolites in healthy subjects.
After an overnight fast, subjects will be administered one dose of 14C-labelled GFT505
containing an equivalent of 120 mg of the compound with 240 mL of non-carbonated water. The
total amount of administered radiocarbon will be 1.63-1.81 megaBecquerel (MBq) (44.1-48.8
μCi).
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. The metabolic profile of GFT505 will be
assayed in plasma, urine, and feces. Non-radioactive pharmacokinetics of GFT505 and its
principle metabolite GFT1007 will be assayed in plasma and urine. 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.
;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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