Healthy VolunteersPhase 1NCT02091310
Phase I Study to Evaluate the Effect of GFT505 on QT/QTc Interval in Healthy Volunteers
A Phase 1 study testing GFT505 and Moxifloxacin 400 mg in people with Healthy Volunteers, run by Genfit at 1 site in France.
Trial summary
In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating its effect on QT/QTc prolongation in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GFT505 and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Feb 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part I:
- Healthy males aged 18 to 45 years inclusive
- Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m²
- No clinically relevant abnormalities in blood pressure (BP) or heart rate (HR)
- No clinically relevant abnormalities in 12-lead ECG results
- Part II:
Show all 11Show fewer
- Healthy males and females aged 18 to 45 years inclusive
- For female subjects of childbearing potential, use of double contraception method
- Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m²
- No clinically relevant abnormalities in blood pressure (BP) or heart rate (HR)
- No clinically relevant abnormalities in 12-lead ECG results
Who cannot join
- Part I:
- Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases
- A history of risk factors for "Torsades de Pointe" (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study
- Current drug or alcohol abuse [including regular alcohol drinking of more than 21 units per week (1 unit = 4 cL spirits or equivalent)] or a history of drug or alcohol abuse within 1 year before screening
- Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center
Show all 20Show fewer
- Use of caffeine containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical center
- Blood donation or loss of significant amount of blood within 2 months prior to the first dosing
- Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject.
- Part II:
- Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases
- A history of risk factors for "Torsades de Pointe" (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
- Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study
- Current drug or alcohol abuse [including regular alcohol drinking of more than 21 units (for male) or 14 units (for female) (1 unit = 4 cL spirits or equivalent)] or a history of drug or alcohol abuse within 1 year before screening
- Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center
- Use of caffeine containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine containing beverages during confinement in the clinical center
- Blood donation or loss of significant amount of blood within 2 months prior to the first dosing
- For women: Positive pregnancy test at screening or on Day -2; Pregnancy or trying to become pregnant; Breastfeeding
- Any other condition that in the opinion of the Investigator would interfere with the evaluation of the results or constitute a health risk for the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.
In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating its effect on QT/QTc prolongation in healthy male and female subjects. According to the guidelines, such studies should typically be performed at the expected therapeutic dose and a supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.
GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy overweight subjects (study GFT505-111-7), and both safety and tolerability were very good. However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d. Therefore, the current TQT study will be preceded by a multiple ascending dose study in which the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5 and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which safety and tolerability are considered satisfactory will be the supra-therapeutic dose used in the TQT study.
Read the detailed description
The present trial is split into two successive parts:
- Study Part I is a double-blind, randomized, placebo-controlled study designed to obtain safety, tolerability and pharmacokinetic (PK) data after 14-day multiple oral administrations of once-daily increasing doses of GFT505 (300 and 360 mg) in healthy male subjects. The starting dose of 300 mg/day has been selected on the basis of the results of previous clinical trials and corresponds to the highest dose given in healthy subjects according to a single dose regimen (study GFT505-111-7). A total of 24 male subjects will be included, 12 for each cohort (a cohort corresponding to a dose level). In each cohort, 9 subjects will receive GFT505 and 3 will receive placebo. A Safety Review Committee (SRC) will have a formal meeting after full completion of at least 10 out of 12 subjects of each dose level to review under blinded conditions all safety data and to conclude on the safety and tolerability of a given dose level. Between the first and the second dose level, the SRC will give its agreement on the dose escalation, and at completion of the second level the SRC will define the supra-therapeutic dose to be administered in Study Part II.
- Study Part II will be a parallel group, randomized, placebo-controlled study, with stratification by gender. The study is designed to investigate the potential impact of 14-day multiple oral administrations of once-daily GFT505 on QT/QTc prolongation under conditions of maximal GFT505 exposure, i.e. by administering the expected therapeutic dose of 120 mg/d and a supra-therapeutic dose (defined according to the results of Study Part I), to healthy male and female subjects. A single oral dose of 400 mg moxifloxacin will be used as a positive control in order to document the sensitivity of the experimental conditions. The study treatment administration will be double-blind for placebo and GFT505 and open for moxifloxacin. The ECG readings will be performed under blinded conditions. A preliminary sample size of 128 subjects to have at least 124 evaluable subjects has been fixed by formal justification on a theoretical basis. ECG data collected during Study Part I will support a formal determination using observed data and thus will lead to a final sample size. In all cases, it is anticipated that the sample size could not be less than 124 evaluable subjects. Each gender will represent at least 40% of the study population. Both sub-groups will be balanced between the 4 treatment groups.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, GFT505, Moxifloxacin 400 mg
- Keywords
- GFT505, TQT, QT/QTc, Pharmacokinetic, Healthy subjects, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
GFT505Drug
Moxifloxacin 400 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Study Part I) | Placebo comparator | Hard gelatin capsules, oral administration, 5 or 6 capsules per day before breakfast with a glass of water Receives: Drug: Placebo |
| GFT505 300 mg (Study Part I) | Experimental | Hard gelatin capsules dosed at 60mg, oral administration, 5 capsules per day before breakfast with a glass of water Receives: Drug: GFT505 |
| GFT505 360 mg (Study Part I) | Experimental | Hard gelatin capsules dosed at 60mg, oral administration, 6 capsules per day before breakfast with a glass of water Receives: Drug: GFT505 |
| Placebo (Study Part II) | Placebo comparator | Hard gelatin capsules, oral administration, 4 to 6 capsules per day before breakfast with a glass of water Receives: Drug: Placebo |
| GFT505 120 mg (Study Part II) | Experimental | Hard gelatin capsules dosed at 60mg, oral administration, 2 capsules per day plus 2 to 4 capsules of placebo per day before breakfast with a glass of water Receives: Drug: GFT505 |
| GFT505 xx mg (Study Part II) | Experimental | Supra-therapeutic dose: hard gelatin capsules dosed at 60mg, oral administration, 4 to 6 capsules per day before breakfast with a glass of water Receives: Drug: GFT505 |
| Moxifloxacin 400 mg (Study Part II) | Active comparator | On days 1 to 13, 4 to 6 placebo capsules per day, then one 400 mg moxifloxacin tablet (Izilox®, Bayer Pharmaceuticals Corporation) administered orally on Day 14 Receives: Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters such as adverse event monitoring, vital signs, ECG, and clinical laboratory tests (Study Part I)
To evaluate the safety and tolerability of two dose levels of GFT505 (300 and 360 mg), after multiple dose administration once daily for 14 days in male healthy subjects in order to determine the supra-therapeutic dose to be administered in Study Part II.
Measured: 14 days
Effect on QTcF compared to placebo (Study Part II)
To evaluate the impact on QTcF of two dose levels (one therapeutic and one supra-therapeutic according to ICH E14) of GFT505, after multiple dose administration once daily for 14 days in healthy male and female subjects compared to placebo and a positive control.
Measured: 14 days
Secondary outcomes (3)
Pharmacokinetic parameters including Cmax, Tmax, AUCt (Study Part I)
To determine the PK parameters of GFT505 and GFT1007 after multiple dose administration once daily for 14 days in male subjects.
Measured: 14 days
Safety parameters such as adverse event monitoring, vital signs, ECG, and clinical laboratory tests (Study Part II)
To evaluate the safety and tolerability of GFT505 in healthy male and female subjects after multiple dose administration of a therapeutic dose and a supra-therapeutic dose
Measured: 14 days
Effect on QTcB compared to placebo (Study Part II)
To evaluate the impact on QTcB of two dose levels (one therapeutic and one supra-therapeutic according to ICH E14) of GFT505, after multiple dose administration once daily for 14 days in healthy male and female subjects compared to placebo and a positive control.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed, CardiaBase, PhinC Development
- Responsible party
- Sponsor
- Investigators
- Rémy Hanf, PhD, Study director, Genfit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091310
- Sponsor's protocol ID
- GFT505-113-9
- Other IDs
- 2013-005154-30
- Status last verified
- Mar 2015
- First submitted
- 14 Mar 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.
- ClinicalTrials.gov ID
- NCT02091310
- Acronym / sponsor ID
- GFT505-113-9
- Conditions
- Healthy Volunteers
- Keywords
- GFT505, TQT, QT/QTc, Pharmacokinetic, Healthy subjects, Moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed, CardiaBase, PhinC Development
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Mar 2014 (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.
In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating its effect on QT/QTc prolongation in healthy male and female subjects. According to the guidelines, such studies should typically be performed at the expected therapeutic dose and a supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.
GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy overweight subjects (study GFT505-111-7), and both safety and tolerability were very good. However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d. Therefore, the current TQT study will be preceded by a multiple ascending dose study in which the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5 and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which safety and tolerability are considered satisfactory will be the supra-therapeutic dose used in the TQT study.
Detailed description
The present trial is split into two successive parts:
- Study Part I is a double-blind, randomized, placebo-controlled study designed to obtain safety, tolerability and pharmacokinetic (PK) data after 14-day multiple oral administrations of once-daily increasing doses of GFT505 (300 and 360 mg) in healthy male subjects. The starting dose of 300 mg/day has been selected on the basis of the results of previous clinical trials and corresponds to the highest dose given in healthy subjects according to a single dose regimen (study GFT505-111-7). A total of 24 male subjects will be included, 12 for each cohort (a cohort corresponding to a dose level). In each cohort, 9 subjects will receive GFT505 and 3 will receive placebo. A Safety Review Committee (SRC) will have a formal meeting after full completion of at least 10 out of 12 subjects of each dose level to review under blinded conditions all safety data and to conclude on the safety and tolerability of a given dose level. Between the first and the second dose level, the SRC will give its agreement on the dose escalation, and at completion of the second level the SRC will define the supra-therapeutic dose to be administered in Study Part II.
- Study Part II will be a parallel group, randomized, placebo-controlled study, with stratification by gender. The study is designed to investigate the potential impact of 14-day multiple oral administrations of once-daily GFT505 on QT/QTc prolongation under conditions of maximal GFT505 exposure, i.e. by administering the expected therapeutic dose of 120 mg/d and a supra-therapeutic dose (defined according to the results of Study Part I), to healthy male and female subjects. A single oral dose of 400 mg moxifloxacin will be used as a positive control in order to document the sensitivity of the experimental conditions. The study treatment administration will be double-blind for placebo and GFT505 and open for moxifloxacin. The ECG readings will be performed under blinded conditions. A preliminary sample size of 128 subjects to have at least 124 evaluable subjects has been fixed by formal justification on a theoretical basis. ECG data collected during Study Part I will support a formal determination using observed data and thus will lead to a final sample size. In all cases, it is anticipated that the sample size could not be less than 124 evaluable subjects. Each gender will represent at least 40% of the study population. Both sub-groups will be balanced between the 4 treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo (Study Part I) | Placebo comparator | Drug: PlaceboHard gelatin capsules, oral administration, 5 or 6 capsules per day before breakfast with a glass of water |
| GFT505 300 mg (Study Part I) | Experimental | Drug: GFT505Hard gelatin capsules dosed at 60mg, oral administration, 5 capsules per day before breakfast with a glass of water |
| GFT505 360 mg (Study Part I) | Experimental | Drug: GFT505Hard gelatin capsules dosed at 60mg, oral administration, 6 capsules per day before breakfast with a glass of water |
| Placebo (Study Part II) | Placebo comparator | Drug: PlaceboHard gelatin capsules, oral administration, 4 to 6 capsules per day before breakfast with a glass of water |
| GFT505 120 mg (Study Part II) | Experimental | Drug: GFT505Hard gelatin capsules dosed at 60mg, oral administration, 2 capsules per day plus 2 to 4 capsules of placebo per day before breakfast with a glass of water |
| GFT505 xx mg (Study Part II) | Experimental | Drug: GFT505Supra-therapeutic dose: hard gelatin capsules dosed at 60mg, oral administration, 4 to 6 capsules per day before breakfast with a glass of water |
| Moxifloxacin 400 mg (Study Part II) | Active comparator | Drug: Moxifloxacin 400 mgOn days 1 to 13, 4 to 6 placebo capsules per day, then one 400 mg moxifloxacin tablet (Izilox®, Bayer Pharmaceuticals Corporation) administered orally on Day 14 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males aged 18 to 45 years inclusive
- Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m²
- No clinically relevant abnormalities in blood pressure (BP) or heart rate (HR)
- No clinically relevant abnormalities in 12-lead ECG results
- Healthy males and females aged 18 to 45 years inclusive
Key exclusion criteria (20 listed)
- Evidence of clinically relevant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases
- A history of risk factors for "Torsades de Pointe" (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Any condition requiring regular concomitant medication, including herbal products and over-the-counter (OTC) medication or predicted need of any concomitant medication during the study
- Current drug or alcohol abuse [including regular alcohol drinking of more than 21 units per week (1 unit = 4 cL spirits or equivalent)] or a history of drug or alcohol abuse within 1 year before screening
- Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center
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 |
|---|---|---|
| Placebo | Drug | Placebo (Study Part I), Placebo (Study Part II) |
| GFT505 | Drug | GFT505 120 mg (Study Part II), GFT505 300 mg (Study Part I), GFT505 360 mg (Study Part I), GFT505 xx mg (Study Part II) |
| Moxifloxacin 400 mg | Drug | Moxifloxacin 400 mg (Study Part II) |
Primary outcome
Safety parameters such as adverse event monitoring, vital signs, ECG, and clinical laboratory tests (Study Part I)
Time frame: 14 days
To evaluate the safety and tolerability of two dose levels of GFT505 (300 and 360 mg), after multiple dose administration once daily for 14 days in male healthy subjects in order to determine the supra-therapeutic dose to be administered in Study Part II.
Effect on QTcF compared to placebo (Study Part II)
Time frame: 14 days
To evaluate the impact on QTcF of two dose levels (one therapeutic and one supra-therapeutic according to ICH E14) of GFT505, after multiple dose administration once daily for 14 days in healthy male and female subjects compared to placebo and a positive control.
3 secondary outcomes
Pharmacokinetic parameters including Cmax, Tmax, AUCt (Study Part I)
Time frame: 14 days
Safety parameters such as adverse event monitoring, vital signs, ECG, and clinical laboratory tests (Study Part II)
Time frame: 14 days
Effect on QTcB compared to placebo (Study Part II)
Time frame: 14 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 10 Mar 2015.
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Healthy Participants
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, PhD study director
Genfit
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 and Moxifloxacin 400 mg in people with Healthy Volunteers, 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 11 inclusion and 20 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 10 Mar 2015. 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?
Safety parameters such as adverse event monitoring, vital signs, ECG, and clinical laboratory tests (Study Part I) (time frame: 14 days). 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 10 Mar 2015.