HealthyPhase 1NCT03937258

A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants

A Phase 1 study testing PF-04965842 and Probenecid in people with Healthy, run by Pfizer at 1 site in United States.

Completed

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

Trial summary

A total of approximately 12 healthy male or female participants will be enrolled in the study so that at least 10 participants will complete the study. Participants will be screened within 28 days of the first dose of study medication. The single fixed-sequence will consist of 3 periods. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-04965842 and Probenecid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 21 May 2019to 26 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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12-lead ECG, and clinical laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent , which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Evidence of acute exacerbation of dermatological condition (eg, AD, eczema or psoriasis) or visible rash present during physical examination. Participants with history of psoriasis, AD or eczema can be included in the study.
Participants, who according to the product label for probenecid, would be at increased risk if dosed with probenecid, including participants with known blood dyscrasias, uric acid kidney stones, gout, or gouty arthritis.
Any condition possibly affecting drug absorption (eg, gastrectomy).
Known relevant history or current elevations of liver function tests (LFTs) or impaired liver function.
History of active or latent or inadequately treated tuberculosis (TB) infection, or a positive QuantiFERON- TB Gold test.
Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of screening. History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized multi-dermatomal herpes zoster.

Show all 30Show fewer

History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus antibody (HCVAb). Hepatitis B vaccination is allowed.
History or evidence of any malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
A positive urine drug test.
Screening supine systolic blood pressure (BP) <= 140 mm Hg or <90 mm Hg, following at least 5 minutes of supine rest OR Screening supine diastolic BP <50 mm Hg or >= 90 mm Hg following at least 5 minutes of supine rest. If a participant meets any of these criteria, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
Absolute neutrophil count of <1200/mm3;
Hemoglobin <10.0 g/dL or hematocrit <30%;
Absolute lymphocyte count <500/mm3;
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level>= 2 * upper limit of normal (ULN);
Total bilirubin level >1 * ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN;
Uric acid not within the normal reference range;
Platelet count of <150,000/mm3;
Estimated creatinine clearance <40 mL/min based on the age appropriate calculation, or serum creatine >1.5 times the ULN.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
Pregnant female participants; breastfeeding female participants; female participants of childbearing potential who are unwilling or unable to use 1 highly effective method of contraception as outlined in this protocol Contraception section for the duration of the study and for at least 28 days after the last dose of investigational product.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ASSESS SINGLE DOSE AND MULTIPLE DOSE PHARMACOKINETICS OF PF-04965842 AND ITS METABOLITES, AND THE EFFECT OF REPEAT-DOSE PROBENECID ON THE SINGLE DOSE PHARMACOKINETICS OF PF-04965842 AND ITS METABOLITES IN HEALTHY PARTICIPANTS

A total of approximately 12 healthy male or female participants will be enrolled in the study so that at least 10 participants will complete the study.

Participants will be screened within 28 days of the first dose of study medication. The single fixed-sequence will consist of 3 periods. Participants will report to the clinical research unit (CRU) at least 12 hours prior to Day 1 dosing in Period 1 and will be required to stay in the CRU for 12 days and 11 nights. Genotyping samples for cytochrome P450 (CYP) 2C19 and CYP2C9 will be collected pre dose in Period 1 only.

In Period 1, participants will be administered a single oral 200 mg dose of PF-04965842 in the morning on Day 1 under fasted conditions (overnight fasting for at least 10 hours). No food will be allowed for at least 4 hours postdose and undergo serial blood sample collection for 48 hours postdose.

In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions (overnight fasting for at least 10 hours). No food will be allowed for at least 4 hours postdose and undergo serial blood sample collection for 48 hours postdose on Day 4.

In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose. Participants will remain in a fasted state for 4 hours after dosing with PF 04965842 and undergo serial blood sample collection for 48 hours post PF 04965842 dosing. Participants will be discharged from the CRU on Day 4 after all study procedures are completed. The participant will be required to have a Follow-up phone contact 28-35 days after the last dose of investigational product.

Conditions: Healthy
Being tested: PF-04965842, Probenecid
Keywords: healthy volunteers

What participants receive

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

PF-04965842Drug
Participants will be administered a single oral 200 mg dose of PF-04965842 in the morning on Period 1 Day 1 and Period 3 Day 2 under fasted conditions. In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions
ProbenecidDrug
In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose.

Study groups in NCT03937258
Study group	Role	What they receive
PF-04965842 single dose	Other	In Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions. Receives: Drug: PF-04965842
PF-04965842 multiple doses	Other	In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions. Receives: Drug: PF-04965842
Probenecid and PF-04965842	Other	In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose. Receives: Drug: PF-04965842; Drug: Probenecid

What is being measured

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

Maximum observed plasma concentration (Cmax) of PF-04965842
Measured: Period 1 Day 1, and Period 3 Day 2.
Area under the curve from time zero to extrapolated infinite time (AUCinf) of PF-04965842
Measured: Period 1 Day 1 and Period 3 Day 2
AUC from time 0 to the time of the last quantifiable concentration (AUClast) of PF-04965842
Measured: Period 1 Day 1 and Period 3 Day 2
Area under the plasma concentration-time profile from time 0-24hr (AUCtau) of PF-04965842
Measured: Period 1 Day 1

Secondary outcomes (4)

Number of subjects with adverse events (AEs).
Number of subjects with adverse events (AEs).
Measured: Screening up to 28-35 days after the last dose of PF 04965842 in period 3
Number of subjects with laboratory tests findings of potential clinical importance
Number of subjects with laboratory tests findings of potential clinical importance
Measured: Screening up to Period 3 Day 4
Number of subjects with clinically significant abnormal vital signs
Number of subjects with clinically significant abnormal vital signs
Measured: Screenig up to Period 3 Day 4
Number of subjects with clinically significant abnormal Electrocardiograms (ECGs)
Number of subjects with clinically significant abnormal Electrocardiograms (ECGs).
Measured: Screening up to Period 3 Day 4

Timeline

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

21 May 201926 Jul 2019

First posted3 May 2019
Study start21 May 2019
Primary completion26 Jul 2019
Study completion26 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Other
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03937258
Sponsor's protocol ID: B7451043
Status last verified: Oct 2019
First submitted: 1 May 2019
Last updated: 18 Oct 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Wang X, Dowty ME, Wouters A, Tatulych S, Connell CA, Le VH, Tripathy S, O'Gorman MT, Winton JA, Yin N, Valdez H, Malhotra BK. Assessment of the Effects of Inhibition or Induction of CYP2C19 and CYP2C9 Enzymes, or Inhibition of OAT3, on the Pharmacokinetics of Abrocitinib and Its Metabolites in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2022 May;47(3):419-429. doi: 10.1007/s13318-021-00745-6. Epub 2022 Feb 28.
PubMed 35226304
Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
PubMed 35061234

Want to know more?

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

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

Questions to ask the study team

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

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ASSESS SINGLE DOSE AND MULTIPLE DOSE PHARMACOKINETICS OF PF-04965842 AND ITS METABOLITES, AND THE EFFECT OF REPEAT-DOSE PROBENECID ON THE SINGLE DOSE PHARMACOKINETICS OF PF-04965842 AND ITS METABOLITES IN HEALTHY PARTICIPANTS
ClinicalTrials.gov ID: NCT03937258
Acronym / sponsor ID: B7451043
Conditions: Healthy
Keywords: healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 21 May 2019 (actual)
Primary completion: 26 Jul 2019 (actual)
Study completion: 26 Jul 2019 (actual)
First posted: 3 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.

A total of approximately 12 healthy male or female participants will be enrolled in the study so that at least 10 participants will complete the study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
PF-04965842 single dose	Other	Drug: PF-04965842In Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions.
PF-04965842 multiple doses	Other	Drug: PF-04965842In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions.
Probenecid and PF-04965842	Other	Drug: PF-04965842, Drug: ProbenecidIn Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including detailed medical history, full physical examination, including blood pressure (BP) and pulse rate measurement, 12-lead ECG, and clinical laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent , which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Key exclusion criteria (30 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Evidence of acute exacerbation of dermatological condition (eg, AD, eczema or psoriasis) or visible rash present during physical examination. Participants with history of psoriasis, AD or eczema can be included in the study.
Participants, who according to the product label for probenecid, would be at increased risk if dosed with probenecid, including participants with known blood dyscrasias, uric acid kidney stones, gout, or gouty arthritis.
Any condition possibly affecting drug absorption (eg, gastrectomy).
Known relevant history or current elevations of liver function tests (LFTs) or impaired liver function.
History of active or latent or inadequately treated tuberculosis (TB) infection, or a positive QuantiFERON- TB Gold test.

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
PF-04965842Participants will be administered a single oral 200 mg dose of PF-04965842 in the morning on Period 1 Day 1 and Period 3 Day 2 under fasted conditions. In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions	Drug	PF-04965842 multiple doses, PF-04965842 single dose, Probenecid and PF-04965842
ProbenecidIn Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose.	Drug	Probenecid and PF-04965842

Primary outcome

Maximum observed plasma concentration (Cmax) of PF-04965842
Time frame: Period 1 Day 1, and Period 3 Day 2.
Area under the curve from time zero to extrapolated infinite time (AUCinf) of PF-04965842
Time frame: Period 1 Day 1 and Period 3 Day 2
AUC from time 0 to the time of the last quantifiable concentration (AUClast) of PF-04965842
Time frame: Period 1 Day 1 and Period 3 Day 2
Area under the plasma concentration-time profile from time 0-24hr (AUCtau) of PF-04965842
Time frame: Period 1 Day 1

4 secondary outcomes

Number of subjects with adverse events (AEs).
Time frame: Screening up to 28-35 days after the last dose of PF 04965842 in period 3
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: Screening up to Period 3 Day 4
Number of subjects with clinically significant abnormal vital signs
Time frame: Screenig up to Period 3 Day 4
Number of subjects with clinically significant abnormal Electrocardiograms (ECGs)
Time frame: Screening up to Period 3 Day 4

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 18 Oct 2019.
Derived from this study: PubMed 35226304Wang X, Dowty ME, Wouters A, Tatulych S, Connell CA, Le VH, Tripathy S, O'Gorman MT, Winton JA, Yin N, Valdez H, Malhotra BK. Assessment of the Effects of Inhibition or Induction of CYP2C19 and CYP2C9 Enzymes, or Inhibition of OAT3, on the Pharmacokinetics of Abrocitinib and Its Metabolites in Healthy Individuals. Eur J Drug Metab Pharmacokinet. 2022 May;47(3):419-429. doi: 10.1007/s13318-021-00745-6. Epub 2022 Feb 28.
Derived from this study: PubMed 35061234Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

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 PF-04965842 and Probenecid in people with Healthy, run by Pfizer at 1 site 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 5 inclusion and 30 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 18 Oct 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 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?

Maximum observed plasma concentration (Cmax) of PF-04965842 (time frame: Period 1 Day 1, and Period 3 Day 2.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937258, which also lists 2 linked publications.

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 18 Oct 2019.