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Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers

NCT02142127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

14C-labelled GFT505 120 mg

Sponsors & Collaborators

  • SGS Life Sciences, a division of SGS Belgium NV

    collaborator OTHER

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Sophie Megnien, MD · Chief Medical Officer, Genfit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2015-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02142127 on ClinicalTrials.gov