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Clinical Trial Details

Trial ID: L6468
Source ID: NCT01474161
Associated Drug: Gft505 120mg - Old Formulation
Title: Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Diabetes Mellitus, Type 2|Metabolic Diseases|Cardiovascular Diseases|Obese|Dyslipidemia
Interventions: DRUG: GFT505 120mg - old formulation|DRUG: GFT505 120mg - new formulation|DRUG: GFT505 180mg - new formulation|DRUG: GFT505 240mg - new formulation|DRUG: GFT505 300mg - new formulation|DRUG: Placebo
Outcome Measures: Primary: Pharmacokinetics parameters (Study Part I), 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., 24h post-dose|Safety parameters (Study Parts II, III and IV), 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)., Part II : 5 days ; Part III : 20 days ; Part IV : 20 days | Secondary: Safety parameters (Study Part I), 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)., 12 days for male and 5 days for female|Pharmacokinetics parameters (Study Parts II, III and IV), Study Part II : For each subject of each dose level, 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. Study Part III and Study Part IV : Assuming a once daily administration, blood will be collected at the following time points: * Day 1 pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 h post-dose. * Days 3, 7, 10, 11, 12 and 13 pre-dose. * Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, and 24 h post-dose., Part II : 24h post-dose ; Part III : 15 days ; Part IV : 15 days
Sponsor/Collaborators: Sponsor: Genfit | Collaborators: SGS Aster S.A.S.|Naturalpha
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 96
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-11
Completion Date: 2012-11
Results First Posted:
Last Update Posted: 2012-11-27
Locations: SGS Aster S.A.S. - Phase I Clinical Unit, Paris, 75015, France
URL: https://clinicaltrials.gov/show/NCT01474161