Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

NCT ID: NCT03765671

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2019-06-14

Brief Summary

This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg.

Conditions

Hepatic Impairment; Liver Disease; Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mild Child-Pugh A

Single oral dose of elafibranor 120mg

Group Type: EXPERIMENTAL

Elafibranor

Intervention Type: DRUG

120mg oral single dose

Moderate Child-Pugh B

Single oral dose of elafibranor 120mg

Group Type: EXPERIMENTAL

Elafibranor

Intervention Type: DRUG

120mg oral single dose

Severe Child-Pugh C

Single oral dose of elafibranor 120mg

Group Type: EXPERIMENTAL

Elafibranor

Intervention Type: DRUG

120mg oral single dose

Healthy

Single oral dose of elafibranor 120mg

Group Type: EXPERIMENTAL

Elafibranor

Intervention Type: DRUG

120mg oral single dose

Interventions

Elafibranor

120mg oral single dose

Intervention Type: DRUG

Other Intervention Names

GFT505

Eligibility Criteria

Inclusion Criteria

• For all participants:

1. Males or females, between 18 and 75 years of age, inclusive;

2. With a minimum body weight of 50 kg and within a BMI range of 18.0 to 40.0 kg/m², inclusive;

3. Females participating in this study must be of non-childbearing potential or using highly efficient contraception for the full duration of the study

4. Negative serum pregnancy test at screening (if applicable);

5. Negative human immunodeficiency virus antibody screens at Screening;

• For hepatically impaired participants:

6. Participants who have chronic (≥ 6 months) mild, moderate, or severe hepatic insufficiency (of any etiology) that has been clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to Screening Currently on a stable medication regimen

• For healthy volunteers with normal hepatic function:

7. Non-smokers

8. Matched to participants with Mild and/or Moderate and/or Severe hepatic impairment in age (± 10 years), BMI (± 20 percent) and gender.

Exclusion Criteria

• For all participants:

1. A positive alcohol test result at Check-in;

2. A history of alcohol abuse in the prior 2 years;

3. Positive urine screen for drugs of abuse at Screening or Check-in.

4. Strenuous exercise within 72 hours prior to Check-in;

5. Blood donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing;

6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs except that appendectomy and hernia repair will be allowed. Bariatric surgery will not be allowed.

7. Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma;

8. Poor peripheral venous access;

9. Receipt of blood products within 2 months prior to Check-in;

• For hepatically impaired participants:

10. History of unstable diabetes mellitus Subjects who have a transjugular intrahepatic portosystemic shunt and/or have undergone portacaval shunting;

11. Participant has shown evidence of hepatorenal syndrome or has creatinine clearance ≤ 60 mL/min Subject has required treatment for GI bleeding within the 6 months prior to Check in;

12. Recent history of paracentesis (< 3 months prior to Check-in);

13. Participants with Wilson's disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia;

14. Participants with anemia secondary to hepatic disease, unless hemoglobin is ≥ 9 g/dL and anemia symptoms are not clinically significant. Subjects must have ≥ 35 000 platelets at screening and at Day -1;

• For healthy volunteers with normal hepatic function:

15. Significant history or clinical manifestation of any metabolic (including thyroid), allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder;

16. Positive serologic test for hepatitis B surface antigen or for hepatitis C virus antibody at Screening;

17. Frequent headaches (> twice a month) and/or migraines, recurrent nausea and/or vomiting;

18. Participants with symptomatic hypotension at Screening, whatever the decrease of blood pressure, or asymptomatic postural hypotension;

19. Cholecystectomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

Genfit

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal BIRMAN, MD

Role: STUDY_DIRECTOR

Genfit

Locations

Division of Clinical Pharmacology, University of Miami

Miami, Florida, United States

inVentiv Health Clinical Research

Miami, Florida, United States

Countries

United States

Other Identifiers

GFT505-118-14

Identifier Type: -

Identifier Source: org_study_id