Type 2 DiabetesPhase 1NCT01474161
Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
A Phase 1 study testing GFT505 120mg - old formulation, GFT505 120mg - new formulation and GFT505 180mg - new formulation in people with Type 2 Diabetes and Diabetes Mellitus, Type 2, run by Genfit at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Diabetes Mellitus, Type 2, Metabolic Diseases
- What is being tested?
- GFT505 120mg - old formulation, GFT505 120mg - new formulation and GFT505 180mg - new formulation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator.
- Part II and III :
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- Male healthy volunteers 18 to 55 years of age (inclusive).
- Subjects with a BMI >28 and <35 kg/m2 at screening.
- Normal arterial BP and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator.
- Part IV :
- Male or female Type 2 diabetic patients 18 to 60 years of age.
- Females participating in the study must be either of non-child bearing potential or using an efficient double contraception.
- Currently treated with any antidiabetic treatment (a maximum of two anti-diabetic drugs including metformin in all cases) with the exception of insulin or GLP analogs and agonists therapy.
- Stable diabetes with glycosylated hemoglobin (HbA1c) < or =10% or less.
- Normal renal function as defined by a creatine clearance >90 mL/min calculated with the Cockcroft-Gault formula.
- Subjects with a BMI from 18 to 32 kg/m2 at screening.
Who cannot join
- Part I :
- Who previously received GFT505.
- With any clinically significant abnormality following review of prestudy laboratory tests (Aspartate and Alanine aminotransferase must be within normal ranges), vital signs, full physical examination and Electrocardiogram.
- Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 (Human immunodeficiency virus) or anti-HCV (Hepatitis C virus) antibodies.
- Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol).
- Who drink more than 8 cups daily of beverage containing caffeine.
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- Who have a positive laboratory test for urine drug screening (opiates, cocaine, amphetamine, cannabis, benzodiazepines).
- Who have undergone surgery or have donated blood within 12 weeks prior to the start of the study.
- Who have taken any prescribed or over the counter drug (including antacid drug), with the exception of paracetamol (up to 3 g per day) within 2 weeks prior to the first dose administration.
- Part II and III : specific additional exclusion criteria
- Who have taken fibrates within 6 weeks prior to the first dose administration.
- Part IV : specific additional exclusion criteria
- With unstable proliferative retinopathy, macular oedema (fundus examination performed in the previous year will be considered relevant on Investigator's judgement).
- Who have taken fibrates within 6 weeks prior to the first dose administration.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases, Obese, Dyslipidemia
- Being tested
- GFT505 120mg - old formulation, GFT505 120mg - new formulation, GFT505 180mg - new formulation, GFT505 240mg - new formulation, GFT505 300mg - new formulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFT505 120mg - old formulationDrug
hard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water.
GFT505 120mg - new formulationDrug
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 formulationDrug
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 formulationDrug
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 formulationDrug
hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water.
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Matching placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| GFT505 20mg - old formulation | Active comparator | Study Part I : dose level = 120mg Receives: Drug: GFT505 120mg - old formulation |
| 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. Receives: Drug: GFT505 120mg - new formulation; Drug: GFT505 180mg - new formulation; Drug: GFT505 240mg - new formulation; Drug: GFT505 300mg - new formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Part II : 5 days ; Part III : 20 days ; Part IV : 20 days
Secondary outcomes (2)
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).
Measured: 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.
Measured: Part II : 24h post-dose ; Part III : 15 days ; Part IV : 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Aster S.A.S., Naturalpha
- Responsible party
- Sponsor
- Investigators
- Rémy Hanf, Development Director, Study director, GENFIT, FrancePhilippe Betting, MD, Principal investigator, SGS Aster S.A.S., Phase I Clinical Unit, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474161
- Sponsor's protocol ID
- GFT505-111-7
- Other IDs
- 2011-004723-13
- Status last verified
- Nov 2012
- First submitted
- 15 Nov 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01474161
- Acronym / sponsor ID
- GFT505-111-7
- Conditions
- Type 2 Diabetes, Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases, Obese, Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Collaborators
- SGS Aster S.A.S., Naturalpha
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Matching placebo | Placebo comparator | Drug: Placebo |
| GFT505 20mg - old formulation | Active comparator | Drug: GFT505 120mg - old formulationStudy Part I : dose level = 120mg |
| GFT505 60mg - new formulation | Experimental | Drug: GFT505 120mg - new formulation, Drug: GFT505 180mg - new formulation, Drug: GFT505 240mg - new formulation, Drug: GFT505 300mg - new formulationStudy 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator.
- Male healthy volunteers 18 to 55 years of age (inclusive).
Key exclusion criteria (14 listed)
- Who previously received GFT505.
- With any clinically significant abnormality following review of prestudy laboratory tests (Aspartate and Alanine aminotransferase must be within normal ranges), vital signs, full physical examination and Electrocardiogram.
- Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 (Human immunodeficiency virus) or anti-HCV (Hepatitis C virus) antibodies.
- Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol).
- Who drink more than 8 cups daily of beverage containing caffeine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFT505 120mg - old formulationhard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water. | Drug | GFT505 20mg - old formulation |
| GFT505 120mg - new formulationhard 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 60mg - new formulation |
| GFT505 180mg - new formulationhard 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 60mg - new formulation |
| GFT505 240mg - new formulationhard 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 60mg - new formulation |
| GFT505 300mg - new formulationhard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water. | Drug | GFT505 60mg - new formulation |
| Placebohard 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). | Drug | Matching placebo |
Primary outcome
Pharmacokinetics parameters (Study Part I)
Time frame: 24h post-dose
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.
Safety parameters (Study Parts II, III and IV)
Time frame: Part II : 5 days ; Part III : 20 days ; Part IV : 20 days
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).
2 secondary outcomes
Safety parameters (Study Part I)
Time frame: 12 days for male and 5 days for female
Pharmacokinetics parameters (Study Parts II, III and IV)
Time frame: Part II : 24h post-dose ; Part III : 15 days ; Part IV : 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémy Hanf, Development Director study director
GENFIT, France
Philippe Betting, MD principal investigator
SGS Aster S.A.S., Phase I Clinical Unit, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GFT505 120mg - old formulation, GFT505 120mg - new formulation and GFT505 180mg - new formulation in people with Type 2 Diabetes and Diabetes Mellitus, Type 2, run by Genfit at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameters (Study Part I) (time frame: 24h post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.