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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01474161 | Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505 | PHASE1 | COMPLETED | 96 | — | — | Nov 1, 2011 | Nov 1, 2012 | Nov 27, 2012 | 1 | France |
For each subject at each Treatment Period, blood will be collected at the following time points: pre-dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 h post-dose.
Monitoring for the occurrence of AEs. Changes in physical examination, vital signs (blood pressure and pulse rate), ECG, and clinical laboratory tests (biochemistry, hematology, and urinalysis).
| Arm | Type | Description |
|---|---|---|
| Matching placebo | PLACEBO_COMPARATOR | - |
| GFT505 20mg - old formulation | ACTIVE_COMPARATOR | Study Part I : dose level = 120mg |
| GFT505 60mg - new formulation | EXPERIMENTAL | Study Part I : dose level = 120mg ; Study Part II : dose level = 180mg, 240mg and 300mg ; Study Part III : dose level = 120mg, 180mg and 240mg ; Study Part IV : dose level = 120mg or 180mg. |
| Name | Type | Description |
|---|---|---|
| GFT505 120mg - old formulation | DRUG | hard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water. |
| GFT505 120mg - new formulation | DRUG | hard gelatin capsules dosed at 60mg, one single oral administration (Study Part I) or multiple dose administration from Day 1 to Day 14 (Study Part III and IV), 2 capsules with 250mL of water. |
| GFT505 180mg - new formulation | DRUG | hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II) or multiple dose administration from Day 1 to Day 14 (Study Part III and IV), 3 capsules with 250mL of water. |
| GFT505 240mg - new formulation | DRUG | hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II) or multiple dose administration from Day 1 to Day 14 (Study Part III), 4 capsules with 250mL of water. |
| GFT505 300mg - new formulation | DRUG | hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water. |
| Placebo | DRUG | hard gelatin capsules, one single oral administration (3 to 5 capsules with 250mL of water for Study Part II) or multiple dose administration from Day 1 to Day 14 (2 to 4 capsules with 250mL of water for Study Part III). |
Inclusion Criteria: Part I : * Male or female healthy volunteers 18 to 45 years of age (inclusive). * Subjects with a body mass index (BMI) ≥ 18 and ≤ 28 kg/m2 at screening. * For female subjects of childbearing potential, use of double contraception method. * Normal arterial blood pressure (BP) a...