Healthy SubjectsPhase 1NCT03633487
Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet
A Phase 1 study testing Mucinex® in people with Healthy Subjects, run by Reckitt Benckiser LLC.
Trial summary
Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Mucinex®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2011to 15 Oct 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females ≥19 to 55 years of age inclusive.
- All females who were of childbearing potential must have been using one of the following acceptable birth control methods for the time periods specified:
- Intrauterine device (IUD) in place for at least 3 months prior to Day 1 through 30 days beyond study completion.
- Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion.
- Stable hormonal contraceptive (oral, depo injection, transdermal patch, or vaginal ring) for at least 3 months prior to Day 1 through 30 days beyond completion of study.
- Note: Abstinence (sexually inactive) was not an acceptable form of contraception; however, abstinent female subjects could have been admitted to the study if they had reported being abstinent at least 14 days prior to screening and they agreed, and signed an "Abstinence Statement" to the effect, that upon becoming sexually active, they would use a condom with spermicide from that time through 30 days beyond completion of the study.
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- Females of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 or post-menopausal ≥2 years prior to Day 1). A follicle stimulating hormone level (FSH) >40 mIU/mL must have been obtained and in the record for any post-menopausal female.
- Negative serum pregnancy test at Screening and at Check-in for all female subjects.
- Good general health as determined by the PI's review of medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements (after 2 minutes resting in the seated position), and clinical laboratory measures.
- Body mass index (BMI) of 19 to 29 kg/m2, inclusive. (BMI = weight (kg)/[height (m2)]).
- Non-tobacco users, who had not used nicotine or nicotine-containing products for at least 6 months prior to Day 1.
- Negative finding on tests for Hepatitis B surface antigen (HBsAG), Hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV).
- Negative urine screen for drugs of abuse and alcohol at Screening and at Check-in.
- Likely to be compliant with study requirements and complete the study, as determined by the Investigator.
- Able to read, understand, and sign the informed consent after the nature of the study had been explained and had read, signed, and dated an Institutional Review Board (IRB)-approved informed consent form for subjects to participate in the study.
Who cannot join
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the PI). If the subject's hemoglobin dropped below 11.0 gm/dL during the study, the subject may have been dropped from the study at the discretion of the PI/designee.
- Any disease or condition, which could impact absorption, distribution, metabolism, or elimination of the study drug (as determined by the PI/designee).
- Females who were pregnant or nursing.
- History of hypersensitivity reaction to guaifenesin.
- Receipt of an investigational drug within 30 days prior to Day 1.
- Abnormal diet (for whatever reason) during the 30 days prior to Day 1.
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- Donation of blood or significant loss of blood within 56 days prior to Day 1.
- Donation of plasma within 14 days prior to Day 1.
- Known or suspected use of illicit drugs (i.e., opiates, barbiturates, marijuana, et. al.).
- The use of any medication, prescription or over-the-counter (OTC) (including herbal supplements) within the 14 days or 5 half-lives of the drug (whichever was longer) prior to Day 1 (with the exception of hormonal contraceptives for women of child-bearing potential).
- Alcoholism or medicinal product or drug abuse within the past two years or excessive alcohol consumption (more than 10 units per week) [one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., "hard" liquor such as gin, whiskey, or vodka, et. al.)]. The subject was not to experience tolerance, withdrawal, compulsive use, or substance related problems such as medical complications, disruption in social and family relationships, vocational or financial difficulties, or legal problems.
- Consumption of grapefruit, pummelo, Seville orange, or grapefruit juice within 14 days prior to dosing on Day 1 through study completion.
- Consumption of alcohol within the 48 hours prior to dosing on Day 1.
- Persons involved directly with the conduct of this study (i.e., Investigator, Sub-Investigators, Study Coordinators, etc.) or employees of Reckitt Benckiser and their families.
About this study
Official title: A Phase I, Open-label, Single-dose, Single Period Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Bi-layer Tablet in Normal Healthy Subjects.
Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
Read the detailed description
A Phase I, Open-Label, Single-Dose, Single Period Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects
- Conditions
- Healthy Subjects
- Being tested
- Mucinex®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucinex®Drug
Also called guaifenesin
Mucinex® 1200 mg ER Bi-Layer tablet
| Study group | Role | What they receive |
|---|---|---|
| Mucinex® 1200 mg | Experimental | Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet (single dose) Receives: Drug: Mucinex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetic Parameters (Cmax) Maximum observed plasma concentration.
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Time of the Maximum Observed Plasma Concentration (Tmax)
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)
Pharmacokinetic Parameter (AUC0-t) is Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Pharmacokinetic Parameter (AUC0-inf) Area under the plasma concentration versus time curve from time 0 to infinity.
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Percentage of AUC0-inf Extrapolated Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Pharmacokinetic Parameter (AUC%extrap) Percent of AUC0-inf extrapolated AUCR = 100 - (AUC0-t/ AUC0-inf) x 100
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Apparent First-order Terminal Elimination Rate Constant (Kel)
Pharmacokinetic Parameter (Kel) Apparent first-order terminal elimination rate constant
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Terminal Elimination Half Life (t1/2)
Pharmacokinetic Parameter (t1/2) is Apparent terminal elimination half-life.
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Time at Which the Percentage of Subjects Achieved a Target Concentration of at Least 65 ng/mL (T65)
Pharmacokinetic Parameter (T65) is te time when guaifenesin plasma concentration achieved a target concentration of at least 65 ng/mL.
Measured: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Secondary outcomes (1)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Intensity was determined by the Investigator. For symptomatic adverse events (AEs) the following definitions were applied.
Mild = AE did not limit usual activities; subject may have experienced slight discomfort.
Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.
Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.
Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.
Measured: Up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start11 Oct 2011
- Primary completion15 Oct 2011
- Study completion15 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633487
- Sponsor's protocol ID
- 2011-MUC-05
- Status last verified
- Feb 2019
- First submitted
- 14 Aug 2018
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-dose, Single Period Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Bi-layer Tablet in Normal Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03633487
- Acronym / sponsor ID
- 2011-MUC-05
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2011 (actual)
- Primary completion
- 15 Oct 2011 (actual)
- Study completion
- 15 Oct 2011 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
Detailed description
A Phase I, Open-Label, Single-Dose, Single Period Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucinex® 1200 mg | Experimental | Drug: Mucinex®Mucinex® 1200 mg Extended-Release (ER) Bi-Layer tablet (single dose) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Males and females ≥19 to 55 years of age inclusive.
- All females who were of childbearing potential must have been using one of the following acceptable birth control methods for the time periods specified:
- Note: Abstinence (sexually inactive) was not an acceptable form of contraception; however, abstinent female subjects could have been admitted to the study if they had reported being abstinent at least 14 days prior to screening and they agreed, and signed an "Abstinence Statement" to the effect, that upon becoming sexually active, they would use a condom with spermicide from that time through 30 days beyond completion of the study.
- Females of non-childbearing potential must have been surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to Day 1 or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 or post-menopausal ≥2 years prior to Day 1). A follicle stimulating hormone level (FSH) >40 mIU/mL must have been obtained and in the record for any post-menopausal female.
- Negative serum pregnancy test at Screening and at Check-in for all female subjects.
Key exclusion criteria (14 listed)
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the PI). If the subject's hemoglobin dropped below 11.0 gm/dL during the study, the subject may have been dropped from the study at the discretion of the PI/designee.
- Any disease or condition, which could impact absorption, distribution, metabolism, or elimination of the study drug (as determined by the PI/designee).
- Females who were pregnant or nursing.
- History of hypersensitivity reaction to guaifenesin.
- Receipt of an investigational drug within 30 days prior to Day 1.
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 |
|---|---|---|
| Mucinex®Also: guaifenesinMucinex® 1200 mg ER Bi-Layer tablet | Drug | Mucinex® 1200 mg |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameters (Cmax) Maximum observed plasma concentration.
Time of the Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (AUC0-t) is Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (AUC0-inf) Area under the plasma concentration versus time curve from time 0 to infinity.
Percentage of AUC0-inf Extrapolated Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (AUC%extrap) Percent of AUC0-inf extrapolated AUCR = 100 - (AUC0-t/ AUC0-inf) x 100
Apparent First-order Terminal Elimination Rate Constant (Kel)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (Kel) Apparent first-order terminal elimination rate constant
Terminal Elimination Half Life (t1/2)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (t1/2) is Apparent terminal elimination half-life.
Time at Which the Percentage of Subjects Achieved a Target Concentration of at Least 65 ng/mL (T65)
Time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1
Pharmacokinetic Parameter (T65) is te time when guaifenesin plasma concentration achieved a target concentration of at least 65 ng/mL.
1 secondary outcome
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mucinex® in people with Healthy Subjects, run by Reckitt Benckiser LLC.
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 15 inclusion and 14 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1). The study lists 8 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 28 Feb 2019.