A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet

NCT05564208 | Completed Phase 1

• 2 other identifiers: CLIN-60190-4522022-001883-91
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

Pharmacokinetics; Elafibranor

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  Day 1 up to Day 10

• PK of Elafibranor's Metabolite GFT1007: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)

  Day 1 up to Day 10

• PK of Elafibranor's Metabolite GFT1007: Maximum Observed Plasma (peak) Drug Concentration (Cmax)

  Day 1 up to Day 10

• PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Half-life (t1/2)

  Day 1 up to Day 10

• PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)

  Day 1 up to Day 10

Study Arms (2)

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.

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.

Drug: elafibranor

Interventions

elafibranor DRUG

Oral Tablet

Also known as: GFT505, IPN60190

Elafibranor Fasting then Elafibranor fed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• ≤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 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:
• mmHg≤systolic blood pressure (SBP)≤145 mmHg,
• mmHg≤diastolic blood pressure (DBP)≤90 mmHg,
• 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.

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 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
• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

BIOTRIAL

Rennes, 35000, France

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

• Ipse Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: October 27, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 14, 2023
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)