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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 an investigational small molecule being studied in healthy volunteers. It is a radiolabeled form of GFT505 used in a mass balance study to track the drug's absorption, distribution, metabolism, and excretion in the body. The study is in Phase 1 and has been completed.
14C-labelled GFT505 is developed by Genfit SA, a biopharmaceutical company. Genfit is publicly traded under the ticker symbol GNFT. The company sponsored a Phase 1 mass balance study of this radiolabeled compound in healthy volunteers.
14C-labelled GFT505 is in Phase 1 clinical development. The single clinical trial for this compound has been completed. It is an investigational drug and is not approved for any medical use. The study enrolled healthy volunteers to evaluate the drug's mass balance.
14C-labelled GFT505 has one completed clinical trial, registered as NCT02142127. The trial is titled "Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers." It was a Phase 1, uncontrolled study conducted in Belgium, enrolling 6 healthy male participants aged 55 years and older.
14C-labelled GFT505 is a radiolabeled version of GFT505, where the compound is labeled with carbon-14. This labeling allows researchers to track the drug's movement through the body in a mass balance study. The study was designed to understand how GFT505 is processed in healthy volunteers.