GeriatricsPhase 1NCT04171752
Elafibranor Pharmacokinetic Parameters in Elderly Healthy Volunteers
A Phase 1 study testing elafibranor in people with Geriatrics and Healthy, run by Genfit at 1 site in France.
Trial summary
In the elderly, pharmacokinetics is altered. Gastric juice pH is elevated which influences drug solubility and absorption. Drug distribution is decreased in the elderly because of decreased cardiac output, increased peripheral vascular resistance, diminished blood flow in the liver and the kidneys, reduced total… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatrics, Healthy
- 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
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2019to 30 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For All Participants:
- Provide written informed consent prior to the conduct of any study related procedures;
- With a minimum body weight (BW) of 50 kg and within a Body Mass Index (BMI) range of 18.0 to 30.0 kg/m^2 (all inclusive) at Screening visit;
- Medically healthy as determined by the Investigator or medically qualified designee at both Screening and Inclusion visits. This will include no variation of BW of more than 5 percent between Screening and Inclusion visits;
- Absence of clinically relevant abnormalities identified by a detailed medical history and complete physical examination;
- Healthy participants, as determined by Normal Blood Pressure (BP) and Heart Rate (HR) at the screening and Inclusion visits after 5 minutes in supine position;
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- Normal ECG recording on a 12-lead ECG at the screening and Inclusion visits and no sign of any trouble of sinusal automatism, or considered as non clinically significant by investigator;
- Laboratory parameters within the normal range of the laboratory;
- Able to comprehend and willing to sign an Informed Consent Form, and to abide by the study restrictions;
- Non-smoker participant or smoker of not more than 5 cigarettes/day within 3 months prior to Inclusion visit, and able to restrain from smoking during the whole study duration;
- Participant with normal dietary habits;
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research;
- For Healthy Young Volunteers only:
- Males or females, between 18 and 45 years of age (all inclusive) at screening;
- Matched to healthy elderly participants by BMI (plus or minus 20 percent) and gender;
- Females participating in this study must be of non-childbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment;
- Females of childbearing potential must have a negative qualitative serum pregnancy test at Screening visit and a negative urine pregnancy test at Inclusion visit;
- For Elderly volunteers only:
- Males or females aged 75 years old or older at Screening visit;
- Participants with mild, chronic, stable disease and stable treatment dose - no change in dose for the 3 months prior to Screening visit - (hypertension, hyperlipidemia, osteoarthritis, treated benign prostate hypertrophy, stable and treated hypothyroidism, treated glaucoma);
- Participants with suitable veins for cannulation or repeated venipuncture.
Who cannot join
- For all participants:
- Participants with a history of noncompliance to medical regimens;
- Participant who, in the opinion of the Investigator, is likely to be not respectful or not cooperative during the study, or unable to cooperate because of a language problem or a mental deficiency;
- Participant who cannot be contacted in case of emergency;
- Participant who is in the exclusion period of a previous study;
- Administrative or legal supervision;
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- Inability to abstain from intensive muscular effort;
- Participant 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;
- A positive alcohol test result or urine screen for drugs of abuse result at Screening or Inclusion visits;
- Any history or suspicion of alcohol abuse;
- Any history or suspicion of consumption of any drug of abuse (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, methamphetamines, methadone, methylenedioxymethamphetamine, opiates, tricyclic antidepressant), from screening to end of the study;
- Consumption of nutritional supplements, herb-containing drug preparations (including Chinese medicines) or other foods or beverages (e.g., grapefruit and xanthine-containing foods or beverages) that may affect drug-metabolizing enzymes or transporters from screening to end of the study visit;
- Evidence or history of gastrointestinal, hepatic, or renal disease, surgery or resection that would potentially alter absorption, distribution, metabolism, or excretion of orally administered drugs;
- Participants who have clinically significant disease of cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, neurological (central nervous system), psychiatric, systemic, infectious disorders or malignant tumor;
- General anesthesia within 3 months before administration;
- History or presence of allergy or unusual reactions to some drugs or anesthetics or known hypersensibility to the investigation product or its excipients;
- Major surgery within 28 days prior to Screening visit or major surgery planned within 6 months following participation to the study;
- Blood donation within 2 months before administration or blood donation planned during the study or within 2 months following participation to the study;
- Receipt of blood products within 2 months prior to Inclusion visit;
- Participants with symptomatic hypotension at Screening visit, whatever the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP ≥ 20 mmHg or DBP ≥ 10 mmHg within 3 minutes when changing from the supine to the standing position;
- Frequent headaches and/or migraines, recurrent nausea and/or vomiting;
- Participants who are positive for human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody;
- Significant, uncontrolled, or life-threatening condition or organ or disease;
- Show evidence of active renal disease (e.g. diabetic renal disease, polycystic kidney disease) or estimated glomerular filtration rate <60 mL/min/1.73m²;
- Evidence of pelvic organ prolapsed, incontinence, or fistula of the urogenital system;
- Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or at risk for falls, as judged to be clinically significant by the investigator;
- Any drug intake during the 2 weeks or 5 half-life of the drug preceding the first administration except those defined in concomitant medication section
- For Young Adults Volunteers only:
- Females who are pregnant or breastfeeding. Female participants should not be enrolled if they plan to become pregnant during the time of study participation;
- Any medications (except paracetamol 3g/day or contraception) intake within the 2 weeks or 5 half-life prior to Screening visit;
- Evidence or history of clinically significant metabolic or allergic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Healthy Elderly and Young Adults Volunteers
In the elderly, pharmacokinetics is altered. Gastric juice pH is elevated which influences drug solubility and absorption. Drug distribution is decreased in the elderly because of decreased cardiac output, increased peripheral vascular resistance, diminished blood flow in the liver and the kidneys, reduced total amount of water in the body. Drug metabolism and biotransformation mainly take place in the liver and is often reduced. Drug elimination is altered very often because of reduced excretory (renal and hepatic) function. All these changes may lead to significant pharmacokinetic changes in geriatric population. A formal pharmacokinetic clinical study is being conducted in order to assess the need of dose adjustment in the elderly population.
- Conditions
- Geriatrics, Healthy
- Being tested
- elafibranor
- Keywords
- elafibranor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elafibranorDrug
Also called GFT505
elafibranor 120mg is a coated tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Young Adults | Experimental | Single oral dose of elafibranor 120mg Receives: Drug: elafibranor |
| Elderly | 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.
Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite
In Healthy Young Adults compared to Healthy Elderly
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite
In Healthy Young Adults compared to Healthy Elderly
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: maximum plasma drug concentration (Cmax) of elafibranor and active metabolite
In Healthy Young Adults compared to Healthy Elderly
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Secondary outcomes (14)
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total area under the plasma
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: time of maximum observed concentration (tmax)
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: maximum plasma drug concentration (Cmax)
For other 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞))
For other 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: Area under curve from dosing time to last measurement (AUC(0-t))
For other 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: renal clearance (CLr)
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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.
- First posted21 Nov 2019
- Study start22 Nov 2019
- Primary completion22 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies 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
- Model description
- Open-label, non-randomized, single-center, single-dose, two arms Phase 1 study in healthy elderly, aged of at least 75 years old (inclusive) and in healthy young adults, aged between 18 and 45 years old (all inclusive)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Birman, MD, Study director, Genfit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171752
- Sponsor's protocol ID
- GFT505-119-16
- Other IDs
- 2019-001819-23, 2019
- Status last verified
- Aug 2020
- First submitted
- 19 Nov 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
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 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Healthy Elderly and Young Adults Volunteers
- ClinicalTrials.gov ID
- NCT04171752
- Acronym / sponsor ID
- GFT505-119-16
- Conditions
- Geriatrics, Healthy
- Keywords
- elafibranor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 22 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 21 Nov 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.
In the elderly, pharmacokinetics is altered. Gastric juice pH is elevated which influences drug solubility and absorption. Drug distribution is decreased in the elderly because of decreased cardiac output, increased peripheral vascular resistance, diminished blood flow in the liver and the kidneys, reduced total amount of water in the body. Drug metabolism and biotransformation mainly take place in the liver and is often reduced. Drug elimination is altered very often because of reduced excretory (renal and hepatic) function. All these changes may lead to significant pharmacokinetic changes in geriatric population. A formal pharmacokinetic clinical study is being conducted in order to assess the need of dose adjustment in the elderly population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, non-randomized, single-center, single-dose, two arms Phase 1 study in healthy elderly, aged of at least 75 years old (inclusive) and in healthy young adults, aged between 18 and 45 years old (all inclusive)
| Arm | Type | Receives |
|---|---|---|
| Young Adults | Experimental | Drug: elafibranorSingle oral dose of elafibranor 120mg |
| Elderly | Experimental | Drug: elafibranorSingle oral dose of elafibranor 120mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- For All Participants:
- Provide written informed consent prior to the conduct of any study related procedures;
- With a minimum body weight (BW) of 50 kg and within a Body Mass Index (BMI) range of 18.0 to 30.0 kg/m^2 (all inclusive) at Screening visit;
- Medically healthy as determined by the Investigator or medically qualified designee at both Screening and Inclusion visits. This will include no variation of BW of more than 5 percent between Screening and Inclusion visits;
- Absence of clinically relevant abnormalities identified by a detailed medical history and complete physical examination;
Key exclusion criteria (31 listed)
- For all participants:
- Participants with a history of noncompliance to medical regimens;
- Participant who, in the opinion of the Investigator, is likely to be not respectful or not cooperative during the study, or unable to cooperate because of a language problem or a mental deficiency;
- Participant who cannot be contacted in case of emergency;
- Participant who is in the exclusion period of a previous study;
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: GFT505elafibranor 120mg is a coated tablet for oral administration | Drug | Elderly, Young Adults |
Primary outcome
Plasma pharmacokinetics: 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
In Healthy Young Adults compared to Healthy Elderly
Plasma pharmacokinetics: 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
In Healthy Young Adults compared to Healthy Elderly
Plasma pharmacokinetics: maximum plasma drug concentration (Cmax) 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
In Healthy Young Adults compared to Healthy Elderly
14 secondary outcomes
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total area under the plasma
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: time of maximum observed concentration (tmax)
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞))
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
Plasma pharmacokinetics: Area under curve from dosing time to last measurement (AUC(0-t))
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers
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
1 site in 1 country: 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 Geriatrics and Healthy, run by Genfit at 1 site in France.
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 21 inclusion and 31 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 1 site in France. 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?
Plasma pharmacokinetics: 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. Additionally, after elafibranor administration at 288 and 384 hours for elderly volunteers). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.