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Healthy VolunteersPhase 1NCT05543369

Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

A Phase 1 study testing Elafibranor in people with Healthy Volunteers, run by Ipsen at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is intended to measure the blood levels of Elafibranor and one of its metabolites in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs, distributes, and eliminates Elafibranor after Repeat Administration, in order to support inclusion of Japanese patients in the planned… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
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
48 participants
Where
2 sitesUnited States
Study dates
19 Sep 2022to 10 Mar 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants should meet one of the following ethnicity criteria:
  • Japanese:
  • Must have been born in Japan.
  • Both the subject's biological parents and all four biological grandparents must be Japanese, as confirmed by interview.
  • Must not be living outside of Japan for more than 10 years.
  • Lifestyle, including diet, has not changed significantly since leaving Japan
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  • Non-Asian:
  • Must be a descent from North America, South America, Europe or the Middle East (subjects from Asian/Pacific Islander and African American descent are excluded).
  • Both the subject's biological parents and all four biological grandparents must be of non-Asian descent
  • Male or female participants must be 18 to 55 years of age (inclusive) at the time of signing the informed consent. A minimum of six evaluable subjects of each sex will have to be completed within each cohort (i.e. at least six female and six male subjects)
  • Has provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
  • 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). Individual values out of the normal range can be accepted if judged non-clinically significant by the investigator.
  • Normal ECG recording on a 12-lead ECG at screening and at admission (Day -1):
  • 120≤PR≤220 ms,
  • QRS<110 ms,
  • 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 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 admission 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 the screening and at admission 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 admission and the participant may be enrolled if at least one repeated value is within the range noted above.
  • Body weight not below 45 kg and body mass index (BMI) within the range 18.0 kg/m^2 and 30.0 kg/m^2
  • Contraception/Barrier Requirements:
  • Female participants:
  • 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 one of the following conditions applies:
  • Is a woman of nonchildbearing potential (WONCBP), or
  • Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the study intervention period and for at least one month after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive pregnancy test (serum as required by local regulations) within 24 hours before dosing with study intervention. The investigator is responsible for review of medical history, menstrual history and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Male participants:
  • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
  • Refrain from donating sperm PLUS, either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or
  • Must agree to use contraception /barrier as detailed below:
  • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak and there remains a risk to pregnant women and women of childbearing potential

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 prior to screening
  • Major surgery within 28 days prior to screening
  • History of COVID-19 infection (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated) within 2 months before dosing
  • 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
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  • Any vaccination during the 4 weeks before enrolment or planned during the clinical study
  • 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
  • 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) Polymerase chain reaction (PCR) test result at screening or admission
  • Positive drugs of abuse/alcohol screen at screening and at admission
  • Positive human immunodeficiency virus (HIV) antibody test at screening
  • Consumption of other foods or beverages (red wine, Seville oranges, grapefruit or grapefruit 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 discharge
  • History of drug or alcohol abuse or excessive intake of alcohol within the 12 months prior to first dosing, or evidence of such abuse as indicated by the laboratory assays conducted at screening or admission. Intake of alcohol above the official recommendation, defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women. Inability to abstain from alcohol for 24 hours before dosing until discharge
  • Inability to abstain from ingesting caffeine- or xanthine containing products (e.g. coffee, tea, cola drinks, energy drinks and chocolate) for 24 hours before dosing until discharge
  • 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 CRU until after their discharge
  • Smoking or use of tobacco or nicotine-containing products (including nicotine patches) within 3 months prior to dosing, during the study until discharge. Status will be confirmed with a urine cotinine at screening and at admission
  • 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

2 sites in 1 country.

United States2 sites

  • Collaborative Neuroscience Research LLC

    Long Beach, California, 90806

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California, 90720

Other trials in United States

About this study

Official title: A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.

This study is intended to measure the blood levels of Elafibranor and one of its metabolites in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs, distributes, and eliminates Elafibranor after Repeat Administration, in order to support inclusion of Japanese patients in the planned clinical studies with elafibranor.

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

    Oral Tablet

Study groups in NCT05543369
Study groupRoleWhat they receive
Cohort 1 : Healthy Japanese ParticipantsExperimentalParticipants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
Receives: Drug: Elafibranor
Cohort 2: Healthy Non-Asian ParticipantsExperimentalParticipants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
Receives: Drug: Elafibranor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Noncompartmental Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ)

    AUCτ will be recorded from the PK blood samples collected.

    Measured: Day 1 and Day 18

  2. Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax)

    Cmax will be recorded from the PK blood samples collected.

    Measured: Day 1 and Day 18

  3. Noncompartmental 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 and Day 18

  4. Noncompartmental PK of Elafibranor and its Metabolite GFT1007: Trough Observed Plasma Concentration Before Dosing or at the end of the Dosing Interval (Ctrough)

    Ctrough will be recorded from the PK blood samples collected.

    Measured: Day 1 and Day 18

  5. Geometric Mean Ratios (GMR) of Elafibranor and and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ) at Steady State

    AUCτ at steady state will be recorded from the PK blood samples collected.

    Measured: Day 18

  6. GMR of Elafibranor and and its Metabolite GFT1007: Maximum (peak) Observed Plasma Drug Concentration (Cmax) at Steady State

    Cmax at steady state will be recorded from the PK blood samples collected.

    Measured: Day 18

Secondary outcomes (5)

  1. 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 19

  2. 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 19

  3. Percentage of Participants With Clinically Significant Changes in 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 19

  4. 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 19

  5. 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 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start19 Sep 2022
  3. Primary completion10 Mar 2023
  4. Study completion10 Mar 2023

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543369
Sponsor's protocol ID
CLIN-60190-450
Status last verified
Feb 2025
First submitted
14 Sep 2022
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elafibranor in people with Healthy Volunteers, run by Ipsen at 2 sites in United States.

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 37 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 2 sites in United States. 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?

Noncompartmental Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ) (time frame: Day 1 and Day 18). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543369.

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.

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