Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02142127 | Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers | PHASE1 | COMPLETED | 6 | — | — | Apr 1, 2014 | Apr 1, 2015 | May 29, 2015 | 1 | Belgium |
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 ...