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Trial record 78 of 3084 for:    Area Under Curve AND Healthy

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

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ClinicalTrials.gov Identifier: NCT03844555
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Genfit

Brief Summary:
This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR<15mL/mn/1.73m^2) versus healthy participants after a single oral administration of elafibranor 120 mg

Condition or disease Intervention/treatment Phase
Renal Impairment Renal Insufficiency Kidney Diseases Pharmacokinetics Drug: Elafibranor Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of Elafibranor 120 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: End Stage Renal Disease
Single oral dose of elafibranor 120mg
Drug: Elafibranor
120mg oral single dose
Other Name: GFT505

Experimental: Healthy
Single oral dose of elafibranor 120mg
Drug: Elafibranor
120mg oral single dose
Other Name: GFT505




Primary Outcome Measures :
  1. Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    In participants with end stage renal disease compared to healthy volunteers

  2. Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    In participants with end stage renal disease compared to healthy volunteers


Secondary Outcome Measures :
  1. Plasma pharmacokinetics: maximum plasma drug concentration (Cmax) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor and metabolites

  2. Plasma pharmacokinetics: elimination half-life (t1/2) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor and metabolites

  3. Plasma pharmacokinetics: apparent volume of distribution (Vd/F) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor

  4. Plasma pharmacokinetics: renal clearance (CLr) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor and metabolites

  5. Plasma pharmacokinetics: apparent non renal clearance (CLnr/F) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor

  6. Plasma pharmacokinetics: apparent total clearance (CL/F) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor

  7. Plasma pharmacokinetics: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total area under the plasma concentration-time curve (%AUCextra) [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for elafibranor and metabolites

  8. Plasma pharmacokinetics: area under curve from dosing time to last measurement (AUC(0-t)) of glucuronide metabolites and corresponding aglycones [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for the glucuronide metabolites of elafibranor and corresponding aglycones

  9. Plasma pharmacokinetics: area under curve from dosing time to infinity (AUC(0-∞)) of glucuronide metabolites and corresponding aglycones [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose ]
    for the glucuronide metabolites of elafibranor and corresponding aglycones

  10. Urine pharmacokinetics: amount excreted (Ae) [ Time Frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose ]
    for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose

  11. Urine pharmacokinetics: cumulative amount excreted (Ae0-t) [ Time Frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose ]
    for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose

  12. Urine pharmacokinetics: percentage of dose excreted (Fe) [ Time Frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose ]
    for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose

  13. Urine pharmacokinetics: cumulative percent of dose excreted (Fe0-t) [ Time Frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose ]
    for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose

  14. Urine pharmacokinetics: renal clearance (CLR) [ Time Frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose ]
    for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For all participants

  1. Male or female subjects, aged 18 to 75 years inclusive;
  2. Females participating in this study must be of non-childbearing potential or using highly efficient contraception for the full duration of the study
  3. Negative serum pregnancy test at screening (if applicable);
  4. Non-smoker subject or smoker of not more than 5 cigarettes a day;

    For Renally Impaired Participants

  5. ESRD patient not yet on dialysis with an estimated glomerular filtration rate (eGFR) <15mL/min/1.73m^2;
  6. Documented renal impairment indicated by reduced eGFR within 12 months of screening or longer;
  7. Stable renal function as evidenced by ≤ 30 percent difference in two evaluation of eGFR on two separate occasions separated by at least 28 days with one measurement being the value at screening;
  8. Body Mass Index (BMI) between 20 and 36 kg/m^2 inclusive.

    For Healthy Volunteers with normal renal function:

  9. eGFR ≥ 90mL/min/1.73m^2;
  10. No proteinuria (< 0.15 g/L determined by urinalysis);
  11. Body Mass Index between 20 and 30 kg/m^2 inclusive and body weight not lower than 55kg;
  12. Matched to at least 1 renal impaired patient by ethnic group, sex, age (+/- 10 years) and BMI (+/- 20 percent).

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

All Participants

  1. Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests;
  2. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day);
  3. Blood donation (including in the frame of a clinical trial) within 2 months before administration or blood donation planned during the study or within 2 months following participation to the study;
  4. Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation;
  5. Positive results of screening for drugs of abuse;
  6. Evidence or history of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic, systemic, infectious, or allergic disease (including drug hypersensitivity or allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
  7. General anesthesia within 3 months before administration;
  8. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.

    For Renally Impaired Participants:

  9. History of renal transplant;
  10. Evidence of an unstable clinically important medical condition other than impaired renal function;
  11. Acute exacerbation or unstable renal function, as indicated by worsening of clinical and/or laboratory signs of renal impairment, within the 4 weeks before study drug administration;
  12. Participants undergoing any method of dialysis or hemofiltration;
  13. Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.);
  14. History of febrile illness within 5 days prior to dosing;
  15. Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase or alanine aminotransferase that is considered clinically significant by the Investigator, etc.). Presence or history of protein drug hypersensitivity, or allergic disease diagnosed and treated by a physician
  16. Any drug intake during the 2 weeks or 5 half-life of the drug preceding the first administration except those defined in the protocol

    For Healthy Volunteers with normal renal function:

  17. Any history or presence of renal disease
  18. Frequent headaches (> twice a month) and / or migraines, recurrent nausea and / or vomiting;
  19. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in Systolic Blood Pressure (≥20 mmHg) or Diastolic Blood Pressure (≥10 mmHg) within three minutes when changing from the supine to the standing position;
  20. Inability to abstain from intensive muscular effort;
  21. Any drug intake (except paracetamol 3g/d or contraception) during the 2 weeks or 5 half-life of the drug preceding the first administration;
  22. Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Other protocol-defined exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844555


Contacts
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Contact: GENFIT +33(0)320164000 clinicaltrial@genfit.com

Locations
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France
Eurofins Optimed Recruiting
Gières, France, 38610
Contact: Yves Donazzolo, MD, MSc         
Romania
ARENSIA Exploratory Medicine Unit, Nephrology Hospital Dr. Carol Davilla Recruiting
Bucharest, Romania, 010701
Contact: Mircea Penescu, MD         
Sponsors and Collaborators
Genfit
Investigators
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Study Director: Pascal Birman, MD Genfit

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Responsible Party: Genfit
ClinicalTrials.gov Identifier: NCT03844555     History of Changes
Other Study ID Numbers: GFT505-118-13
2018-002481-39 ( EudraCT Number )
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Urologic Diseases