Hepatic ImpairmentPhase 1NCT03765671
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
A Phase 1 study testing Elafibranor in people with Hepatic Impairment and Liver Disease, run by Genfit at 2 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Liver Disease, Pharmacokinetics
- 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
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Dec 2018to 14 Jun 2019
- 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:
- 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;
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Clinical Pharmacology, University of Miami
Miami, Florida, 33136
inVentiv Health Clinical Research
Miami, Florida, 33136
About this study
Official title: An Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Adult Subjects With Hepatic Impairment and Adult Healthy Control Subjects
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
- Being tested
- Elafibranor
- Medical subject headings
- Liver 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 group | Role | What they receive |
|---|---|---|
| Mild Child-Pugh A | Experimental | Single oral dose of elafibranor 120mg Receives: Drug: Elafibranor |
| Moderate Child-Pugh B | Experimental | Single oral dose of elafibranor 120mg Receives: Drug: Elafibranor |
| Severe Child-Pugh C | 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 mild, moderate and severe hepatic impairment 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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
Area under curve from dosing time to infinity (AUC(0-∞)) of elafibranor and active metabolite
In participants with mild, moderate and severe hepatic impairment 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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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 hepatic impaired participants
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 hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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 hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
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 posted5 Dec 2018
- Study start12 Dec 2018
- Primary completion7 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genfit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, University of Miami
- Responsible party
- Sponsor
- Investigators
- Pascal BIRMAN, MD, Study director, Genfit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765671
- Sponsor's protocol ID
- GFT505-118-14
- Status last verified
- Aug 2019
- First submitted
- 30 Nov 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Adult Subjects With Hepatic Impairment and Adult Healthy Control Subjects
- ClinicalTrials.gov ID
- NCT03765671
- Acronym / sponsor ID
- GFT505-118-14
- Conditions
- Hepatic Impairment, Liver Disease, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GenfitIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, University of Miami
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 5 Dec 2018 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Child-Pugh A | Experimental | Drug: ElafibranorSingle oral dose of elafibranor 120mg |
| Moderate Child-Pugh B | Experimental | Drug: ElafibranorSingle oral dose of elafibranor 120mg |
| Severe Child-Pugh C | 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 (12 listed)
- 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);
Key exclusion criteria (23 listed)
- 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;
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 | Healthy, Mild Child-Pugh A, Moderate Child-Pugh B, Severe Child-Pugh C |
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
In participants with mild, moderate and severe hepatic impairment 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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
In participants with mild, moderate and severe hepatic impairment 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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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 hepatic impaired participants
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 hepatic impaired participants
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 hepatic impaired participants
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 hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired participants
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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients
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 22 Aug 2019.
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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 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 Hepatic Impairment and Liver Disease, run by Genfit at 2 sites in United States.
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 12 inclusion and 23 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 22 Aug 2019. 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 United States. 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. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients). 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?
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 22 Aug 2019.