HealthyPhase 4NCT02530060

A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants

A Phase 4 study testing Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to healthy Japanese adult male participants. Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteJapan
Study dates: Aug 2015to Sep 2015
Phase: Phase 4
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 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Willing to adhere to the prohibitions and restrictions specified in this protocol
Participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the dose of study drug
Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
Non-smoker or participant who habitually smokes no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

Who cannot join

History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 mL/min), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of the study drug is scheduled until completion of the study
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition text revision or 5th edition) (DSM-IV or DSM-5) criteria or International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as benzodiazepines, cocaines, stimulants, cannabinoids, barbiturates, opiates, phencyclidines, and tricyclic antidepressants) at screening and on Day -1

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Fukuoka

Other trials in Japan

About this study

Official title: An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration of a Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjects

Read the detailed description

This is a single center, open-label, single oral dose study in healthy Japanese adult male participants. The study consists of 3 phases; a screening phase up to 27 days (Day -28 to Day -2), an in-patient phase from Day -1 to Day 3 (dosing day is Day 1), and a follow-up assessment phase from Day 4 to the last follow-up assessment scheduled on Day 15 or at the time of early withdrawal. All participants will receive a single oral dose of one Complera tablet on Day 1 within 5 minutes after completion of the standardized breakfast. Pharmacokinetics of RPV/TFV/FTC will be assessed as the primary objective of the study. Safety of each participant will be assessed throughout the study.

Conditions: Healthy
Being tested: Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC
Keywords: Healthy, Rilpivirine, Tenofovir, Emtricitabine, Tenofovir Disoproxil Fumarate

What participants receive

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

Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDCDrug
Also called Complera
Fixed dose combination tablet contains 25 milligram (mg) of Rilpivirine, 300 mg of Tenofovir Disoproxil Fumarate (TDF) and 200 mg of Emtricitabine (FTC).

Study groups in NCT02530060
Study group	Role	What they receive
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine	Experimental	Participants will receive single oral dose of fixed dose combination (FDC) tablet comprising of Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine on Day 1. Receives: Drug: Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC

What is being measured

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

Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration of rilpivirine, tenofovir, emtricitabine.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte (rilpivirine/tenofovir/emtricitabine) concentration.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve for rilpivirine/tenofovir/emtricitabine from time zero to last quantifiable time.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Elimination Rate Constant (Lambda[z])
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Elimination Half-Life (t1/2)
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Apparent Volume of Distribution (Vdz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vdz/F) is influenced by the fraction absorbed.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Apparent Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose

Secondary outcomes (1)

Number of Participants who Experience Adverse Events
As a measure of safety and tolerability.
Measured: Up to 17 days following study drug administration

Timeline

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

Aug 2015Sep 2015

First posted20 Aug 2015 (estimated)
Study startAug 2015
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02530060
Sponsor's protocol ID: CR107748
Other IDs: TMC278FDCHIV4001
Status last verified: Dec 2016
First submitted: 19 Aug 2015
Last updated: 2 Jan 2017
Results posted: No
Data monitoring committee: No

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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration of a Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjects
ClinicalTrials.gov ID: NCT02530060
Acronym / sponsor ID: CR107748
Conditions: Healthy
Keywords: Healthy, Rilpivirine, Tenofovir, Emtricitabine, Tenofovir Disoproxil Fumarate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 20 Aug 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine	Experimental	Drug: Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDCParticipants will receive single oral dose of fixed dose combination (FDC) tablet comprising of Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine on Day 1.

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Willing to adhere to the prohibitions and restrictions specified in this protocol
Participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the dose of study drug
Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg
Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
Non-smoker or participant who habitually smokes no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

Key exclusion criteria (5 listed)

History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 mL/min), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of the study drug is scheduled until completion of the study
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition text revision or 5th edition) (DSM-IV or DSM-5) criteria or International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as benzodiazepines, cocaines, stimulants, cannabinoids, barbiturates, opiates, phencyclidines, and tricyclic antidepressants) at screening and on 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
Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDCAlso: CompleraFixed dose combination tablet contains 25 milligram (mg) of Rilpivirine, 300 mg of Tenofovir Disoproxil Fumarate (TDF) and 200 mg of Emtricitabine (FTC).	Drug	Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The Cmax is the maximum observed plasma concentration of rilpivirine, tenofovir, emtricitabine.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte (rilpivirine/tenofovir/emtricitabine) concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The AUC (0-last) is the area under the plasma concentration-time curve for rilpivirine/tenofovir/emtricitabine from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Elimination Rate Constant (Lambda[z])
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Elimination Half-Life (t1/2)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Apparent Volume of Distribution (Vdz/F)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vdz/F) is influenced by the fraction absorbed.
Apparent Clearance (CL/F)
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

1 secondary outcome

Number of Participants who Experience Adverse Events
Time frame: Up to 17 days following study drug administration

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 2 Jan 2017.
An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After Single-Oral Administration of Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male SubjectsLink provided by the sponsor.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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.

Janssen Pharmaceutical K.K., Japan Clinical Trials study director

Janssen Pharmaceutical K.K.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

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 5 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 2 Jan 2017. 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 Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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) (time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose). 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?

On the ClinicalTrials.gov record for NCT02530060.

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 2 Jan 2017.