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14C-labelled GFT505 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 14C-labelled GFT505 120 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 14C-labelled GFT505 120 mg | DRUG | - |
Inclusion Criteria: * Healthy Caucasian males aged 55 to 65 years inclusive * Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m² * Fitzpatrick skin type \< 4 * No clinically relevant abnormalities in hematology and clinical chemistry parameters, blood pressure (BP) and heart rate (HR) (supine), or ECG results ...
14C-labelled GFT505 is a radiolabeled version of the small molecule GFT505, used in a Phase 1 mass balance study to trace how the drug is absorbed, metabolized, and excreted in the body. It was tested in healthy male volunteers aged 55 years and older.
14C-labelled GFT505 is used as a research tool in clinical pharmacology, specifically to study the mass balance, metabolism, and excretion pathways of GFT505. It is not a therapeutic treatment; it is administered in a controlled trial setting to healthy volunteers to characterize the drug's pharmacokinetic profile.
14C-labelled GFT505 is being developed by Genfit SA, which trades on the Nasdaq under the ticker GNFT as an American Depositary Receipt. Genfit sponsored the Phase 1 mass balance study of this radiolabeled compound.
14C-labelled GFT505 is in Phase 1 clinical development. It has completed one Phase 1 trial, a mass balance study in healthy volunteers, and is not currently listed as active in further trials. It is an investigational agent and has not been approved by the FDA.
14C-labelled GFT505 has been evaluated in one completed Phase 1 trial: NCT02142127, titled "Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers." The trial enrolled 6 healthy male participants aged 55 years and older in Belgium and was an uncontrolled study.