Renal ImpairmentPhase 1NCT03844555

Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

A Phase 1 study testing Elafibranor in people with Renal Impairment and Renal Insufficiency, run by Genfit at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment, Renal Insufficiency, Kidney Diseases
What is being tested?: Elafibranor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 2 sitesin 2 countries
Study dates: 28 Feb 2019to 21 Mar 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

For all participants
Male or female subjects, aged 18 to 75 years 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);
Non-smoker subject or smoker of not more than 5 cigarettes a day;
For Renally Impaired Participants

Show all 16Show fewer

ESRD patient not yet on dialysis with an estimated glomerular filtration rate (eGFR) <15mL/min/1.73m^2;
Documented renal impairment indicated by reduced eGFR within 12 months of screening or longer;
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;
Body Mass Index (BMI) between 20 and 36 kg/m^2 inclusive.
For Healthy Volunteers with normal renal function:
eGFR ≥ 90mL/min/1.73m^2;
No proteinuria (< 0.15 g/L determined by urinalysis);
Body Mass Index between 20 and 30 kg/m^2 inclusive and body weight not lower than 55kg;
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

Who cannot join

All Participants
Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests;
History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day);
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;
Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation;
Positive results of screening for drugs of abuse;

Show all 26Show fewer

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);
General anesthesia within 3 months before administration;
Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
For Renally Impaired Participants:
History of renal transplant;
Evidence of an unstable clinically important medical condition other than impaired renal function;
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;
Participants undergoing any method of dialysis or hemofiltration;
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.);
History of febrile illness within 5 days prior to dosing;
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
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:
Any history or presence of renal disease
Frequent headaches (> twice a month) and / or migraines, recurrent nausea and / or vomiting;
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;
Inability to abstain from intensive muscular effort;
Any drug intake (except paracetamol 3g/d or contraception) during the 2 weeks or 5 half-life of the drug preceding the first administration;
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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

Eurofins Optimed
Gières, 38610

Other trials in France

Romania1 site

ARENSIA Exploratory Medicine Unit, Nephrology Hospital Dr. Carol Davilla
Bucharest, 010701

Other trials in Romania

About this study

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

Conditions: Renal Impairment, Renal Insufficiency, Kidney Diseases, Pharmacokinetics
Being tested: Elafibranor
Medical subject headings: Renal Insufficiency, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElafibranorDrug
Also called GFT505
120mg oral single dose

Study groups in NCT03844555
Study group	Role	What they receive
End Stage Renal Disease	Experimental	Single oral dose of elafibranor 120mg Receives: Drug: Elafibranor
Healthy	Experimental	Single oral dose of elafibranor 120mg Receives: Drug: Elafibranor

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite
In participants with end stage renal disease compared to healthy volunteers
Measured: 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
Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite
In participants with end stage renal disease compared to healthy volunteers
Measured: 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

Secondary outcomes (14)

Plasma pharmacokinetics: maximum plasma drug concentration (Cmax)
for elafibranor and metabolites
Measured: 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
Plasma pharmacokinetics: elimination half-life (t1/2)
for elafibranor and metabolites
Measured: 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
Plasma pharmacokinetics: apparent volume of distribution (Vd/F)
for elafibranor
Measured: 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
Plasma pharmacokinetics: renal clearance (CLr)
for elafibranor and metabolites
Measured: 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
Plasma pharmacokinetics: apparent non renal clearance (CLnr/F)
for elafibranor
Measured: 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
Plasma pharmacokinetics: apparent total clearance (CL/F)
for elafibranor
Measured: 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
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)
for elafibranor and metabolites
Measured: 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
Plasma pharmacokinetics: area under curve from dosing time to last measurement (AUC(0-t)) of glucuronide metabolites and corresponding aglycones
for the glucuronide metabolites of elafibranor and corresponding aglycones
Measured: 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
Plasma pharmacokinetics: area under curve from dosing time to infinity (AUC(0-∞)) of glucuronide metabolites and corresponding aglycones
for the glucuronide metabolites of elafibranor and corresponding aglycones
Measured: 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
Urine pharmacokinetics: amount excreted (Ae)
for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
Measured: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
Urine pharmacokinetics: cumulative amount excreted (Ae0-t)
for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
Measured: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
Urine pharmacokinetics: percentage of dose excreted (Fe)
for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
Measured: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
Urine pharmacokinetics: cumulative percent of dose excreted (Fe0-t)
for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
Measured: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
Urine pharmacokinetics: renal clearance (CLR)
for elafibranor and metabolites, if applicable. 24 hours urine collection from dosing to 216 hours post-dose
Measured: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201921 Mar 2020

First posted18 Feb 2019
Study start28 Feb 2019
Primary completion15 Mar 2020
Study completion21 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03844555
Sponsor's protocol ID: GFT505-118-13
Other IDs: 2018-002481-39, 2018
Status last verified: Aug 2020
First submitted: 15 Feb 2019
Last updated: 13 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03844555
Acronym / sponsor ID: GFT505-118-13
Conditions: Renal Impairment, Renal Insufficiency, Kidney Diseases, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: GenfitIndustry (pharma, biotech, devices)
Study start: 28 Feb 2019 (actual)
Primary completion: 15 Mar 2020 (actual)
Study completion: 21 Mar 2020 (actual)
First posted: 18 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
End Stage Renal Disease	Experimental	Drug: ElafibranorSingle oral dose of elafibranor 120mg
Healthy	Experimental	Drug: ElafibranorSingle oral dose of elafibranor 120mg

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

For all participants
Male or female subjects, aged 18 to 75 years 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);
Non-smoker subject or smoker of not more than 5 cigarettes a day;

Key exclusion criteria (26 listed)

All Participants
Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests;
History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day);
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;
Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElafibranorAlso: GFT505120mg oral single dose	Drug	End Stage Renal Disease, Healthy

Primary outcome

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
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

14 secondary outcomes

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
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
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
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
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
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
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
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
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
Urine pharmacokinetics: amount excreted (Ae)
Time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose
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
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
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
Urine pharmacokinetics: renal clearance (CLR)
Time frame: pre-dose and then 24, 48, 72, 96, 120, 144, 168, 192, 216 hours post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pascal Birman, MD study director

Genfit

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elafibranor in people with Renal Impairment and Renal Insufficiency, run by Genfit at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03844555.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.