Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-01 @ 1:11 PM
Study NCT ID:
NCT01474161
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2011-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
Sponsor:
Genfit
Organization:
Study Overview
Official Title:
Comparative Bioavailability Study of a New GFT505 Formulation With the Existing One After 120 mg Single Oral GFT505 Administration and Assessment of the Gender Effect in Young Healthy Male and Female Volunteers Followed by a Single and Multiple Ascending Dose Safety, Tolerability and Pharmacokinetic Study of GFT505 in Overweight or Obese Subjects and in Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60 mg GFT505) and the old GFT505 formulation (capsule dosed at 20 mg GFT505) in healthy male subjects and to assess the impact of gender on this relative bioavailability after administration in male and female subjects.
Using the new formulation, a single and a multiple ascending dose study will be performed in overweight or obese male subjects otherwise healthy whose demographic and physiological characteristics are thought to be closer to those of the target population (Type 2 diabetes). Thereafter, a group of male and female patients with Type 2 diabetes will receive multiple dose administration of GFT505.
Using the new formulation, a single and a multiple ascending dose study will be performed in overweight or obese male subjects otherwise healthy whose demographic and physiological characteristics are thought to be closer to those of the target population (Type 2 diabetes). Thereafter, a group of male and female patients with Type 2 diabetes will receive multiple dose administration of GFT505.
Detailed Description:
The study will be divided in 4 successive parts :
* Study Part I will be a comparative bioavailability between a new GFT505 formulation (capsule dosed at 60 mg GFT505 by capsule) and the old GFT505 formulation (capsule dosed at 20 mg GFT505 by capsule) coupled with an evaluation of the gender effect assessed with the new formulation. In this purpose a group of 12 male subjects will receive successively both formulations on a unique occasion in a randomized manner while a group of 12 female subjects will receive the new formulation on one occasion only. This part of the study will be done in healthy volunteers.
* Study Part II will be a single ascending dose to be run at a maximum of 3 dose levels. Subjects included in this part of the study will receive only one dose level to limit the exposure to GFT505. Three cohorts of 8 subjects are planned to be included. This part will be run in overweight or obese subjects.
* Study Part III will start after completion of the first Cohort of Study Part II. Study Part III will be a multiple ascending dose to be run at a maximum of 3 dose levels. Subjects included in this part of the study will receive only one dose level to limit the exposure to GFT505. Three cohorts of 12 subjects are planned to be included. This part will be run in overweight or obese subjects.
* Study Part IV will follow the same design and same treatment schedule than Study Part III but will be performed in the target population, patients with Type 2 diabetes and only one dose will be tested in study part IV.
* Study Part I will be a comparative bioavailability between a new GFT505 formulation (capsule dosed at 60 mg GFT505 by capsule) and the old GFT505 formulation (capsule dosed at 20 mg GFT505 by capsule) coupled with an evaluation of the gender effect assessed with the new formulation. In this purpose a group of 12 male subjects will receive successively both formulations on a unique occasion in a randomized manner while a group of 12 female subjects will receive the new formulation on one occasion only. This part of the study will be done in healthy volunteers.
* Study Part II will be a single ascending dose to be run at a maximum of 3 dose levels. Subjects included in this part of the study will receive only one dose level to limit the exposure to GFT505. Three cohorts of 8 subjects are planned to be included. This part will be run in overweight or obese subjects.
* Study Part III will start after completion of the first Cohort of Study Part II. Study Part III will be a multiple ascending dose to be run at a maximum of 3 dose levels. Subjects included in this part of the study will receive only one dose level to limit the exposure to GFT505. Three cohorts of 12 subjects are planned to be included. This part will be run in overweight or obese subjects.
* Study Part IV will follow the same design and same treatment schedule than Study Part III but will be performed in the target population, patients with Type 2 diabetes and only one dose will be tested in study part IV.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-004723-13 | EUDRACT_NUMBER | None | View |