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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 carbon-14 radiolabeled version of the small molecule GFT505, developed by Genfit SA (ticker GNFT). It was studied in a Phase 1 mass balance trial in healthy male volunteers to trace how the drug is absorbed, metabolized, and excreted by the body.
14C-labelled GFT505 is being developed by Genfit SA, which trades on the Nasdaq under the ticker GNFT as a sponsored ADR. Genfit sponsored the single Phase 1 trial of this radiolabeled compound.
14C-labelled GFT505 is in Phase 1 development. Its only recorded trial, a mass balance study in healthy volunteers, has been completed. The compound is investigational and has not been approved by the FDA.
14C-labelled GFT505 was evaluated in one completed Phase 1 trial, NCT02142127, titled "Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers." The study enrolled 6 male participants aged 55 years and older in Belgium and was an uncontrolled, non-randomized design.