Cardiovascular DiseasePhase 1NCT03948451
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD5718 in Volunteers
A Phase 1 study testing [14C]AZD5718 Oral Suspension in people with Cardiovascular Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease. The study is an open-label, single dose study involving 6 healthy male subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- [14C]AZD5718 Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2019to 2 Jul 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects aged 30 to 65 years with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index of 18.5 to 35.0 kg/m2, and weigh at least 50 kg and no more than 100 kg, as measured at screening.
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
- Must be willing and able to communicate and participate in the whole study.
- Must be surgically sterile or agree to adhere to the contraception requirements.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results of the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Subjects with Gilbert's syndrome or subjects with a history of cholecystectomy or gall stones.
- Any confirmed clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the investigator.
- Any confirmed clinically significant abnormal findings in vital signs, as judged by the investigator.
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- Any confirmed clinically significant abnormal findings in 12-lead ECG, as judged by the investigator.
- Any positive result at screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
- Known or suspected history of drug or alcohol abuse within the past 2 years, as judged by the investigator.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 90 days of the first administration of IMP in this study. The period of exclusion ends 90 days after the final dose. Note: subjects consented and screened, but not enrolled in this study or a previous Phase I study are not excluded.
- Plasma donation within 1 month of screening or any blood donation/loss of more than 500 mL of blood during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718 or the formulation excipients. Hay fever is allowed unless it is active.
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening and admission.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- Confirmed positive screen for drugs of abuse at screening or admission to the clinical unit or positive screen for alcohol at screening or admission to the clinical unit.
- Herbal preparations/medications are not allowed throughout the study. These herbal medications include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto, and ginseng. Subjects should stop using these herbal medications 14 days prior to administration of [14C]AZD5718.
- Use of any prescribed or nonprescribed medication including antacids, H2 antagonists, PPI, analgesics (other than paracetamol/acetaminophen up to 4 g/day), vitamins and minerals during the 14 days prior to administration of [14C]AZD5718 or longer if the medication has a longer half-life (see Section 11.4). Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Known or suspected history of alcohol or drug abuse or regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
- Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (ie during the screening period) minor medical complaints that may interfere with the interpretation of the study data or are considered unlikely to comply with the study procedures, restrictions and requirements.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5718 in Healthy Male Volunteers
The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease.
The study is an open-label, single dose study involving 6 healthy male subjects. The volunteers will receive a single dose of 200 mg radiolabelled AZD5718 (14C-AZD5718 Oral Suspension) containing not more than 9.9 MBq of radiocarbon.
Read more
Volunteers will attend the clinic for 9 days (Day -1 to Day 8) to receive a single dose of the test medicine. It is planned that the volunteers will be discharged as a group once all volunteers have reached the discharge criteria. This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the discharge criteria are not met by volunteers by Day 8, the individual volunteers who have not met the criteria will remain in the clinical unit for a further 48 h (until Day 10).
A follow-up call will take place 7 to 10 days after discharge to ensure the ongoing wellbeing of volunteers.
- Conditions
- Cardiovascular Disease
- Being tested
- [14C]AZD5718 Oral Suspension
- Keywords
- Coronary Artery Disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]AZD5718 Oral SuspensionDrug
Also called [14C]AZD5718
200 mg dose of [14C]AZD5718 Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| [14C]AZD5718 Oral Suspension | Experimental | One 200 mg dose of [14C]AZD5718 Oral Suspension Receives: Drug: [14C]AZD5718 Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of AZD5718 excreted (Ae)
Assessment of the total radioactivity by measuring the amount of AZD5718 excreted (Ae)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Assessment of the total radioactivity by measuring the amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD5718 excreted (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD5718 excreted (CumAe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD5718 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD5718 excreted and expressed as a percentage of the administered dose (CumFe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of urine samples from pre-dose until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Collection of faecal samples from pre-dose until 168 hours post-dose
Time to maximum concentration (tmax) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the time to maximum concentration (tmax)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Maximum plasma concentration (cmax) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the maximum plasma concentration (cmax)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Area under the concentration time curve to the last quantifiable concentration (AUC last) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the concentration time curve to the last quantifiable concentration (AUC last)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Apparent terminal Elimination Half-life (t1/2,λz) for AZD5718 and total radioactivity
Assessment of AZD5718 and total radioactivity by measuring the Elimination Half-life (t1/2,λz)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Oral clearance (CL/F) of AZD5718
Assessment of the oral clearance of AZD5718 by measuring the apparent oral clearance (CL/F)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
Apparent Volume of Distribution (Vz/F) of AZD5718
Assessment of the oral PK (pharmacokinetics) of AZD5718by measuring the Apparent Volume of Distribution (Vz/F)
Measured: Collection of plasma samples from pre-dose until 168 hours post-dose
The amount of AZD5718 excreted (Ae)
Assessment of the oral PK (pharmacokinetics) of AZD5718 by measuring the amount of AZD5718 excreted (Ae)
Measured: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Assessment of the oral PK (pharmacokinetics) of AZD5718 by measuring the amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Measured: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Renal clearance (Clr) in urine of AZD5718
Assessment of the oral PK (pharmacokinetics) by measuring the renal clearance (Clr)
Measured: Collection of urine samples from pre-dose until 168 hours post-dose
Secondary outcomes (2)
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Assessment of total radioactivity in whole blood and plasma
Measured: Blood samples collected until 168 hours post-dose
Number of adverse events (AE) experienced by subjects
Safety and tolerability assessed through incidence of AE
Measured: AEs recorded from the time of informed consent until discharge from the study (168 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 posted14 May 2019
- Study start30 Apr 2019
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Principal investigator, Quotient Sciences Limited (indemnified by Medical Protection Society)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948451
- Sponsor's protocol ID
- D7550C00007
- Status last verified
- Jul 2019
- First submitted
- 1 Apr 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5718 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03948451
- Acronym / sponsor ID
- D7550C00007
- Conditions
- Cardiovascular Disease
- Keywords
- Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 14 May 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.
The Sponsor is developing the test medicine, AZD5718, for the potential treatment of cardiovascular disease.
The study is an open-label, single dose study involving 6 healthy male subjects. The volunteers will receive a single dose of 200 mg radiolabelled AZD5718 (14C-AZD5718 Oral Suspension) containing not more than 9.9 MBq of radiocarbon.
Volunteers will attend the clinic for 9 days (Day -1 to Day 8) to receive a single dose of the test medicine. It is planned that the volunteers will be discharged as a group once all volunteers have reached the discharge criteria. This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the discharge criteria are not met by volunteers by Day 8, the individual volunteers who have not met the criteria will remain in the clinical unit for a further 48 h (until Day 10).
A follow-up call will take place 7 to 10 days after discharge to ensure the ongoing wellbeing of volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]AZD5718 Oral Suspension | Experimental | Drug: [14C]AZD5718 Oral SuspensionOne 200 mg dose of [14C]AZD5718 Oral Suspension |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects aged 30 to 65 years with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index of 18.5 to 35.0 kg/m2, and weigh at least 50 kg and no more than 100 kg, as measured at screening.
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
- Must be willing and able to communicate and participate in the whole study.
Key exclusion criteria (22 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results of the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Subjects with Gilbert's syndrome or subjects with a history of cholecystectomy or gall stones.
- Any confirmed clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the investigator.
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 |
|---|---|---|
| [14C]AZD5718 Oral SuspensionAlso: [14C]AZD5718200 mg dose of [14C]AZD5718 Oral Suspension | Drug | [14C]AZD5718 Oral Suspension |
Primary outcome
The amount of AZD5718 excreted (Ae)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the amount of AZD5718 excreted (Ae)
Amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
The cumulative amount of AZD5718 excreted (CumAe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the cumulative amount of AZD5718 excreted (CumAe)
The cumulative amount of AZD5718 excreted and expressed as a percentage of the administered dose (CumFe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the cumulative amount of AZD5718 excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of urine samples from pre-dose until 168 hours post-dose
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Collection of faecal samples from pre-dose until 168 hours post-dose
Assessment of metabolites and structural identification by assessing liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time to maximum concentration (tmax) for AZD5718 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of AZD5718 and total radioactivity by measuring the time to maximum concentration (tmax)
Maximum plasma concentration (cmax) for AZD5718 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of AZD5718 and total radioactivity by measuring the maximum plasma concentration (cmax)
Area under the concentration time curve to the last quantifiable concentration (AUC last) for AZD5718 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of AZD5718 and total radioactivity by measuring the concentration time curve to the last quantifiable concentration (AUC last)
Area under the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf) for AZD5718 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of AZD5718 and total radioactivity by measuring the concentration time curve from time zero to the last quantifiable concentration (AUC0-inf)
Apparent terminal Elimination Half-life (t1/2,λz) for AZD5718 and total radioactivity
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of AZD5718 and total radioactivity by measuring the Elimination Half-life (t1/2,λz)
Oral clearance (CL/F) of AZD5718
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the oral clearance of AZD5718 by measuring the apparent oral clearance (CL/F)
Apparent Volume of Distribution (Vz/F) of AZD5718
Time frame: Collection of plasma samples from pre-dose until 168 hours post-dose
Assessment of the oral PK (pharmacokinetics) of AZD5718by measuring the Apparent Volume of Distribution (Vz/F)
The amount of AZD5718 excreted (Ae)
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Assessment of the oral PK (pharmacokinetics) of AZD5718 by measuring the amount of AZD5718 excreted (Ae)
Amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Time frame: Collection of urine and faecal samples from pre-dose until 168 hours post-dose
Assessment of the oral PK (pharmacokinetics) of AZD5718 by measuring the amount of AZD5718 excreted and expressed as a percentage of the administered dose (Fe)
Renal clearance (Clr) in urine of AZD5718
Time frame: Collection of urine samples from pre-dose until 168 hours post-dose
Assessment of the oral PK (pharmacokinetics) by measuring the renal clearance (Clr)
2 secondary outcomes
Evaluation of whole blood:plasma concentration ratios for total radioactivity
Time frame: Blood samples collected until 168 hours post-dose
Number of adverse events (AE) experienced by subjects
Time frame: AEs recorded from the time of informed consent until discharge from the study (168 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 15 Jul 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.
Sharan Sidhu, MBChB, BAO, MRCS, MFPM principal investigator
Quotient Sciences Limited (indemnified by Medical Protection Society)
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 [14C]AZD5718 Oral Suspension in people with Cardiovascular Disease, run by AstraZeneca at 1 site in United Kingdom.
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 6 inclusion and 22 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 15 Jul 2019. 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 United Kingdom. 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?
The amount of AZD5718 excreted (Ae) (time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose). The study lists 17 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 15 Jul 2019.