| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Drug-drug Interaction | Drug: elafibranor Drug: CHRONO-INDOCID | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 26 participants |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Open-label, one sequence crossover, single-centre, single group assignment Phase 1 study in healthy male Caucasians volunteers, aged between 18-50 years old (inclusive) |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Phase 1, Open-label Study, in Healthy Male Volunteers to Evaluate the Potential Effect of Indomethacin on the Pharmacokinetics Parameters of Elafibranor |
| Actual Study Start Date : | September 23, 2019 |
| Actual Primary Completion Date : | March 15, 2020 |
| Actual Study Completion Date : | March 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: DDI
Period 1: study of elafibranor's pharmacokinetics Period 2: study of elafibranor's pharmacokinetics under CHRONO-INDOCID® (indomethacin) at steady state
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Drug: elafibranor
Elafibranor 120mg is a coated tablet for oral administration
Other Name: GFT505
Drug: CHRONO-INDOCID CHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration
Other Name: Indomethacin
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Only males are eligible |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
90 mmHg ≤ systolic blood pressure (SBP) ≤ 145 mmHg, 50 mmHg ≤ diastolic blood pressure (DBP) ≤ 90 mmHg, 45 bpm ≤ HR ≤ 90 bpm. Out-of-range values that are not clinically significant, as determined by the Investigator, may be repeated twice and the participant may be enrolled if at least 1 repeated value is within the specified ranges; 7. Normal electrocardiogram (ECG) recording on a 12-lead ECG at both Screening and Inclusion visits: 120 ≤ PR < 220 ms, QRS < 110 ms, QTcf ≤ 430 ms. No sign of any trouble of sinusal automatism, or considered as non clinically significant by the Investigator.
Out-of-range values that are not clinically significant (as determined by the Investigator) may be repeated twice during Screening and Inclusion visits, and the participant may be enrolled if at least 1 repeated value is within the specified normal ranges; 8. Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis) at Screening and Inclusion visits. Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator; 9. Participant with normal dietary habits; 10. Covered by Health Insurance System and in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion Criteria:
Participants presenting with any of the following criteria will not be included in the trial:
| France | |
| Eurofins Optimed Clinical Pharmacology Unit | |
| Gières, France, 38610 | |
| Study Director: | Pascal Birman, MD | Genfit |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 11, 2019 | ||||||
| First Posted Date ICMJE | June 14, 2019 | ||||||
| Last Update Posted Date | August 13, 2020 | ||||||
| Actual Study Start Date ICMJE | September 23, 2019 | ||||||
| Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin | ||||||
| Official Title ICMJE | Phase 1, Open-label Study, in Healthy Male Volunteers to Evaluate the Potential Effect of Indomethacin on the Pharmacokinetics Parameters of Elafibranor | ||||||
| Brief Summary | The enzyme responsible for the conversion of elafibranor into its active metabolite, GFT1007, has not been formally identified, but it is believed to have similar characteristics to an α,β-ketoalkene reductase previously identified in rat liver cytosol. In vitro studies in human liver cytosol fractions have shown that indomethacin inhibits the enzyme responsible of the transformation of elafibranor into GFT1007. As a result, indomethacin was included in the list of prohibited co-medications in all clinical trials with elafibranor, and a formal Drug-Drug Interaction (DDI) clinical study is being conducted to elucidate the effect of indomethacin on elafibranor pharmacokinetics. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Intervention Model: Sequential Assignment Intervention Model Description: Open-label, one sequence crossover, single-centre, single group assignment Phase 1 study in healthy male Caucasians volunteers, aged between 18-50 years old (inclusive) Masking: None (Open Label)Primary Purpose: Basic Science |
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| Condition ICMJE | Drug-drug Interaction | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: DDI
Period 1: study of elafibranor's pharmacokinetics Period 2: study of elafibranor's pharmacokinetics under CHRONO-INDOCID® (indomethacin) at steady state
Interventions:
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
26 | ||||||
| Original Estimated Enrollment ICMJE |
28 | ||||||
| Actual Study Completion Date ICMJE | March 31, 2020 | ||||||
| Actual Primary Completion Date | March 15, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
90 mmHg ≤ systolic blood pressure (SBP) ≤ 145 mmHg, 50 mmHg ≤ diastolic blood pressure (DBP) ≤ 90 mmHg, 45 bpm ≤ HR ≤ 90 bpm. Out-of-range values that are not clinically significant, as determined by the Investigator, may be repeated twice and the participant may be enrolled if at least 1 repeated value is within the specified ranges; 7. Normal electrocardiogram (ECG) recording on a 12-lead ECG at both Screening and Inclusion visits: 120 ≤ PR < 220 ms, QRS < 110 ms, QTcf ≤ 430 ms. No sign of any trouble of sinusal automatism, or considered as non clinically significant by the Investigator. Out-of-range values that are not clinically significant (as determined by the Investigator) may be repeated twice during Screening and Inclusion visits, and the participant may be enrolled if at least 1 repeated value is within the specified normal ranges; 8. Laboratory parameters within the normal range of the laboratory (haematological, blood chemistry tests, urinalysis) at Screening and Inclusion visits. Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator; 9. Participant with normal dietary habits; 10. Covered by Health Insurance System and in compliance with the recommendations of National Law in force relating to biomedical research. Exclusion Criteria: Participants presenting with any of the following criteria will not be included in the trial:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | France | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03985969 | ||||||
| Other Study ID Numbers ICMJE | GFT505-119-15 2019-001451-38 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Genfit | ||||||
| Study Sponsor ICMJE | Genfit | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Genfit | ||||||
| Verification Date | August 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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