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GFT505- old formulation · 1 trial · 6 indications
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...
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GFT505 is an investigational small molecule being studied for Type 2 Diabetes. It is also being evaluated in the context of metabolic diseases, cardiovascular diseases, obesity, and dyslipidemia. The drug is in Phase 1 clinical development and is not yet approved.
GFT505 is being developed by Genfit SA Sponsored ADR, a biopharmaceutical company. The company's ticker symbol is GNFT. The drug is currently in Phase 1 clinical development for Type 2 Diabetes.
GFT505 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for Type 2 Diabetes and related metabolic conditions.
GFT505 has one completed Phase 1 clinical trial with the identifier NCT01474161. This study was a comparative bioavailability, gender effect, single and multiple ascending dose safety and pharmacokinetic study of GFT505. The trial enrolled 96 participants and was conducted in France.
Yes, GFT505- old formulation refers to the same drug as GFT505. The drug is being developed by Genfit SA Sponsored ADR and is currently in Phase 1 clinical development for Type 2 Diabetes.