Status:
COMPLETED
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
Lead Sponsor:
Genfit
Collaborating Sponsors:
Syneos Health
University of Miami
Conditions:
Hepatic Impairment
Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 (...
Eligibility Criteria
Inclusion
- \- For all participants:
- Males or females, between 18 and 75 years of age, inclusive;
- With a minimum body weight of 50 kg and within a BMI range of 18.0 to 40.0 kg/m², inclusive;
- Females participating in this study must be of non-childbearing potential or using highly efficient contraception for the full duration of the study
- Negative serum pregnancy test at screening (if applicable);
- Negative human immunodeficiency virus antibody screens at Screening;
- For hepatically impaired participants:
- 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:
- Non-smokers
- Matched to participants with Mild and/or Moderate and/or Severe hepatic impairment in age (± 10 years), BMI (± 20 percent) and gender.
- Other protocol-defined inclusion criteria may apply
Exclusion
- \- For all participants:
- A positive alcohol test result at Check-in;
- A history of alcohol abuse in the prior 2 years;
- Positive urine screen for drugs of abuse at Screening or Check-in.
- Strenuous exercise within 72 hours prior to Check-in;
- 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;
- 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.
- Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma;
- Poor peripheral venous access;
- Receipt of blood products within 2 months prior to Check-in;
- For hepatically impaired participants:
- History of unstable diabetes mellitus Subjects who have a transjugular intrahepatic portosystemic shunt and/or have undergone portacaval shunting;
- 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;
- Recent history of paracentesis (\< 3 months prior to Check-in);
- Participants with Wilson's disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia;
- 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:
- 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;
- Positive serologic test for hepatitis B surface antigen or for hepatitis C virus antibody at Screening;
- Frequent headaches (\> twice a month) and/or migraines, recurrent nausea and/or vomiting;
- Participants with symptomatic hypotension at Screening, whatever the decrease of blood pressure, or asymptomatic postural hypotension;
- Cholecystectomy
- Other protocol-defined exclusion criteria may apply
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03765671
Start Date
December 12 2018
End Date
June 14 2019
Last Update
August 22 2019
Active Locations (2)
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1
Division of Clinical Pharmacology, University of Miami
Miami, Florida, United States, 33136
2
inVentiv Health Clinical Research
Miami, Florida, United States, 33136