NCT01474161 - Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions

Type 2 DiabetesDiabetes Mellitus, Type 2Metabolic DiseasesCardiovascular DiseasesObeseDyslipidemia

Interventions

DRUG

GFT505 120mg - old formulation

hard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water.

DRUG

GFT505 120mg - new formulation

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.

DRUG

GFT505 180mg - new formulation

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.

DRUG

GFT505 240mg - new formulation

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.

DRUG

GFT505 300mg - new formulation

hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water.

DRUG

Placebo

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).

Trial Locations (1)

75015

SGS Aster S.A.S. - Phase I Clinical Unit, Paris