Healthy ParticipantsPhase 1NCT05564208
A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
A Phase 1 study testing elafibranor in people with Healthy Participants, run by Ipsen at 1 site in France.
Trial summary
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability). The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- elafibranor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 27 Oct 2022to 14 Jan 2023
- 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
- Willingness to remain at the clinic for the required duration and willingness to return to the clinic for the follow-up evaluation as specified in the protocol
- Healthy participants as determined by medical evaluation at the screening visit including medical history, physical examination, laboratory tests, electrocardiogram (ECG) and vital signs monitoring
- Laboratory parameters within the normal range of the laboratory (haematological, blood biochemistry, urinalysis) at screening and baseline visit of each period. Individual values out of the normal range can be accepted if judged not clinically significant by the investigator
- Normal electrocardiogram (ECG) recording on a 12-lead ECG at screening and baseline visit of each period:
- 120≤PR≤220 ms,
- QRS<110 ms,
Show all 16Show fewer
- QTcF≤430 ms for male and
- ≤450 ms for female,
- No evidence of sinus node automaticity or abnormal conduction, or rhythm disorders of concern, except as considered not 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 baseline visits of each period and the participant may be enrolled if at least one repeated value is within the range noted above.
- Normal blood pressure (BP) and heart rate (HR) at screening and baseline visits of each period after 5 minutes in supine position:
- 90 mmHg≤systolic blood pressure (SBP)≤145 mmHg,
- 50 mmHg≤diastolic blood pressure (DBP)≤90 mmHg,
- 45 bpm≤HR≤90 bpm,
- For these parameters, out-of-range values that are not clinically significant (as determined by the investigator) may be repeated twice during screening and baseline visits of each period and the participant may be enrolled if at least one repeated value is within the range noted above.
- Body weight not below 55 kg and body mass index (BMI) within the range 20.0 kg/m^2 and 28.0 kg/m^2 (inclusive) at screening.
- Contraception/barrier requirements: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study, and is willing to follow applicable protocol requirements related to this. Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception.
Who cannot join
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Lymphoma, leukaemia or any malignancy within the past 5 years except basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to screening
- Breast cancer within the past 10 years at screening
- Major surgery within 28 days prior to screening
- Past or intended use of over the counter (OTC) or prescription medication (including herbal medications or vitamin supplements, nutritional supplements, herb-containing drug preparations (including Chinese medicines)) within 14 days or 5 half-lives of the drug (whichever is longer) prior to dosing. Exceptions are oral contraception/hormone replacement therapy for females and paracetamol/acetaminophen at doses of ≤2 g/day.
- Any vaccination during the 4 weeks before randomisation or planned during the clinical study
Show all 26Show fewer
- Use of any medications within 3 months that may interfere with absorption, distribution, metabolism or excretion of the study intervention, or any medication that may result in induction or inhibition of microsomal enzymes.
- Plasma donation within 14 days of the screening or any blood donation/ blood loss >450 mL during the last 30 days before screening. Blood and/or plasma should not be donated until 30 days after last study intervention.
- Current enrolment or past participation within the last 3 months (or 5 half-lives, whichever is longer) before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Participant who would receive more than 4500 Euro as indemnities for participation in biomedical research within the last 12 months, including the indemnities for the present study.
- Presence of hepatitis B surface antigen (HBsAg) at screening
- Positive hepatitis C antibody test result at screening. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained and sustained viral response can be documented
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. NOTE: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing
- Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test result at screening or during the study
- Positive drugs of abuse/alcohol screen at screening and baseline visit of each period
- Positive human immunodeficiency virus (HIV) antibody test at screening
- Consumption of other foods or beverages (e.g. red wine, Seville oranges, grapefruit orgrapefruit juice (including pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices)) that may affect drug-metabolising enzymes or transporters from 7 days prior to dosing until the end of each study period
- Inability to abstain from caffeine- or xanthine-containing products (e.g. coffee, tea, cola drinks and chocolate) for 24 hours before dosing until after collection of the final PK sample in each period
- Any history or suspicion of alcohol abuse (alcohol consumption >40 g/day). Inability to abstain from alcohol for 24 hours before each period and until after the last sample from each period is collected
- History of illicit drug abuse within the last 12 months
- Sensitivity to any components of the study intervention or other allergy that, in the opinion of the investigator, contraindicates participation in the study, including lactose intolerance
- Inability to abstain from intensive muscular effort. Participants should not engage in any strenuous activity from 72 hours prior to admission to the clinical unit until after their EOS visit
- Smoker. Smoking or use of tobacco or nicotine-containing products within 3 months prior to or during the study. Status will be confirmed with a urine cotinine at screening and at baseline visits of each period
- Had been on a diet incompatible with the on-study diet (i.e. unusual meal habits, special diet requirements or unwillingness to eat the food provided in the study, e.g. vegetarian nor vegan), in the opinion of the investigator or designee, within the 30 days prior to the first dosing and throughout the study
- Venous status at forearm or dorsal hand making it difficult to insert a venous peripheral catheter
- Vulnerable subjects, e.g. kept in detention, protected adults under guardianship, trusteeship or committed to an institution by governmental or juridical order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).
The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC).
PBC is a rare, long-term autoimmune disease of the liver. An autoimmune disease occurs when the immune (defence) system treats healthy parts of the body as if they were foreign and attacks them.
This study will be in healthy volunteers, so this trial is not to test if the drug helps to improve health.
- Conditions
- Healthy Participants
- Being tested
- elafibranor
- Keywords
- Pharmacokinetics, Elafibranor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elafibranorDrug
Also called GFT505, IPN60190
Oral Tablet
elafibranorDrug
Also called GFT505, IPN60190
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Elafibranor Fasting then Elafibranor fed | Experimental | Participants will receive Elafibranor 80 mg in Fasting State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fed State on Day 1 of Period 2. Receives: Drug: elafibranor |
| Elafibranor Fed then Elafibranor fasting | Experimental | Participants will receive Elafibranor 80 mg in Fed State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fasting State on Day 1 of Period 2. Receives: Drug: elafibranor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
AUC0-t will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
AUC0-∞ will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
Secondary outcomes (14)
PK of Elafibranor's Metabolite GFT1007: Area under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
AUC0-t will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
AUC0-∞ will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
Measured: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Half-life (t1/2)
t1/2 will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Tmax will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)
tlag will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)
λz will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Cl/F will be recorded from the PK blood samples collected.
Measured: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vd/F)
Vd/F will be recorded from the PK blood samples collected
Measured: Day 1 up to Day 10
Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs
Measured: Baseline up to Day 21
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator
Measured: Baseline up to Day 21
Percentage of Participants With Clinically Significant Changes in Vital Signs
Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.
Measured: Baseline up to Day 21
Percentage of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
Measured: Baseline up to Day 21
Percentage of Participants With Clinically Significant Changes in Physical Examination
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Measured: Baseline up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start27 Oct 2022
- Primary completion30 Dec 2022
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipse Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564208
- Sponsor's protocol ID
- CLIN-60190-452
- Other IDs
- 2022-001883-91
- Status last verified
- Feb 2025
- First submitted
- 29 Sep 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05564208
- Acronym / sponsor ID
- CLIN-60190-452
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Elafibranor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 3 Oct 2022 (actual)
- 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.
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).
The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC).
PBC is a rare, long-term autoimmune disease of the liver. An autoimmune disease occurs when the immune (defence) system treats healthy parts of the body as if they were foreign and attacks them.
This study will be in healthy volunteers, so this trial is not to test if the drug helps to improve health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elafibranor Fasting then Elafibranor fed | Experimental | Drug: elafibranorParticipants will receive Elafibranor 80 mg in Fasting State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fed State on Day 1 of Period 2. |
| Elafibranor Fed then Elafibranor fasting | Experimental | Drug: elafibranorParticipants will receive Elafibranor 80 mg in Fed State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fasting State on Day 1 of Period 2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Willingness to remain at the clinic for the required duration and willingness to return to the clinic for the follow-up evaluation as specified in the protocol
- Healthy participants as determined by medical evaluation at the screening visit including medical history, physical examination, laboratory tests, electrocardiogram (ECG) and vital signs monitoring
- Laboratory parameters within the normal range of the laboratory (haematological, blood biochemistry, urinalysis) at screening and baseline visit of each period. Individual values out of the normal range can be accepted if judged not clinically significant by the investigator
- Normal electrocardiogram (ECG) recording on a 12-lead ECG at screening and baseline visit of each period:
- No evidence of sinus node automaticity or abnormal conduction, or rhythm disorders of concern, except as considered not 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 baseline visits of each period and the participant may be enrolled if at least one repeated value is within the range noted above.
Key exclusion criteria (26 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Lymphoma, leukaemia or any malignancy within the past 5 years except basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to screening
- Breast cancer within the past 10 years at screening
- Major surgery within 28 days prior to screening
- Past or intended use of over the counter (OTC) or prescription medication (including herbal medications or vitamin supplements, nutritional supplements, herb-containing drug preparations (including Chinese medicines)) within 14 days or 5 half-lives of the drug (whichever is longer) prior to dosing. Exceptions are oral contraception/hormone replacement therapy for females and paracetamol/acetaminophen at doses of ≤2 g/day.
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 |
|---|---|---|
| elafibranorAlso: GFT505, IPN60190Oral Tablet | Drug | Elafibranor Fasting then Elafibranor fed |
| elafibranorAlso: GFT505, IPN60190Oral Tablet | Drug | Elafibranor Fed then Elafibranor fasting |
Primary outcome
Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: Day 1 up to Day 10
AUC0-t will be recorded from the PK blood samples collected.
PK of Elafibranor: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
Time frame: Day 1 up to Day 10
AUC0-∞ will be recorded from the PK blood samples collected.
PK of Elafibranor: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
Time frame: Day 1 up to Day 10
Cmax will be recorded from the PK blood samples collected.
14 secondary outcomes
PK of Elafibranor's Metabolite GFT1007: Area under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
Time frame: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Half-life (t1/2)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vd/F)
Time frame: Day 1 up to Day 10
Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to Day 21
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Time frame: Baseline up to Day 21
Percentage of Participants With Clinically Significant Changes in Vital Signs
Time frame: Baseline up to Day 21
Percentage of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Time frame: Baseline up to Day 21
Percentage of Participants With Clinically Significant Changes in Physical Examination
Time frame: Baseline up to Day 21
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 20 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Ipse Medical Director study director
Ipsen
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 elafibranor in people with Healthy Participants, run by Ipsen 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 26 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 20 Feb 2025. 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. 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 (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t) (time frame: Day 1 up to Day 10). The study lists 3 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 20 Feb 2025.