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

NCT05543369 | Completed Phase 1 FDA Drug

• 1 other identifier: CLIN-60190-450
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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 clinical studies with elafibranor.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Elafibranor

Outcome Measures

Primary Outcomes (6)

• 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.

  Day 1 and Day 18

• 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.

  Day 1 and Day 18

• 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.

  Day 1 and Day 18

• 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.

  Day 1 and Day 18

• 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.

  Day 18

• 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.

  Day 18

Secondary Outcomes (5)

• Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)

  Baseline up to Day 19

• Percentage of Participants With Clinically Significant Changes in Physical Examination

  Baseline up to Day 19

• Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings

  Baseline up to Day 19

• Percentage of Participants With Clinically Significant Changes in Vital Signs

  Baseline up to Day 19

• Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)

  Baseline up to Day 19

Study Arms (2)

Cohort 1 : Healthy Japanese Participants

EXPERIMENTAL

Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.

Drug: Elafibranor

Cohort 2: Healthy Non-Asian Participants

EXPERIMENTAL

Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.

Drug: Elafibranor

Interventions

Elafibranor DRUG

Oral Tablet

Also known as: GFT505

Cohort 1 : Healthy Japanese Participants; Cohort 2: Healthy Non-Asian Participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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):

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (2)

Collaborative Neuroscience Research LLC

Long Beach, California, 90806, United States

Location

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States

Location

Related Links

• Lay language results summary

MeSH Terms

Interventions

2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: September 19, 2022
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)