Healthy SubjectsPhase 1NCT02391623

A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

A Phase 1 study testing PF-06427878 in people with Healthy Subjects, run by Pfizer at 1 site in Belgium.

Completed

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

Trial summary

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: PF-06427878
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteBelgium
Study dates: Mar 2015to Feb 2016
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

Healthy male and/or female subjects of non childbearing potential.
Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

Who cannot join

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit
Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects

Conditions: Healthy Subjects
Being tested: PF-06427878, Placebo
Keywords: Multiple Ascending Dose, Healthy Subjects, Hyperlipidemia, Lipid Metabolism Disorders, Metabolic Diseases
Medical subject headings: Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases

What participants receive

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

PF-06427878Drug
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
PlaceboDrug
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878Drug
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
PlaceboDrug
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).

Study groups in NCT02391623
Study group	Role	What they receive
Cohort 1	Experimental	Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. Receives: Drug: PF-06427878; Drug: Placebo
Cohort 2	Experimental	Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. Receives: Drug: PF-06427878; Drug: Placebo
Cohort 3	Experimental	Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. Receives: Drug: PF-06427878; Drug: Placebo
Cohort 4	Experimental	Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. Receives: Drug: PF-06427878; Drug: Placebo
Cohort 5	Experimental	Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. Receives: Drug: PF-06427878; Drug: Placebo
Cohort 6	Experimental	Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics. Receives: Drug: PF-06427878; Drug: Placebo

What is being measured

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

Assessment of adverse events (AEs).
Measured: 0-25 days
Assessment of clinical laboratory tests.
Measured: 0-25 days
Assessment of vital signs (including blood pressure and pulse rate).
Measured: 0-25 days
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Measured: 0-25 days

Secondary outcomes (20)

Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Measured: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0- tau hours post dose
Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0- tau hours post dose
Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Measured: 0- tau hours post dose

Timeline

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

Mar 2015Feb 2016

First posted18 Mar 2015 (estimated)
Study startMar 2015
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies 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: Basic science
Allocation: Randomised
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02391623
Sponsor's protocol ID: B7871002
Other IDs: 2015-000130-29, 2015
Status last verified: Mar 2016
First submitted: 12 Mar 2015
Last updated: 2 Mar 2016
Results posted: No
Data monitoring committee: No

Publications

Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520):eaav9701. doi: 10.1126/scitranslmed.aav9701.
PubMed 31776293

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 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02391623
Acronym / sponsor ID: B7871002
Conditions: Healthy Subjects
Keywords: Multiple Ascending Dose, Healthy Subjects, Hyperlipidemia, Lipid Metabolism Disorders, Metabolic Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 18 Mar 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Cohort 1	Experimental	Drug: PF-06427878, Drug: PlaceboSingle dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 2	Experimental	Drug: PF-06427878, Drug: PlaceboSingle dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 3	Experimental	Drug: PF-06427878, Drug: PlaceboSingle dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 4	Experimental	Drug: PF-06427878, Drug: PlaceboSingle dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 5	Experimental	Drug: PF-06427878, Drug: PlaceboSingle dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
Cohort 6	Experimental	Drug: PF-06427878, Drug: PlaceboSingle dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male and/or female subjects of non childbearing potential.
Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

Key exclusion criteria (1 listed)

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

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-06427878PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5
PlaceboPlacebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5
PF-06427878PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).	Drug	Cohort 6
PlaceboPlacebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).	Drug	Cohort 6

Primary outcome

Assessment of adverse events (AEs).
Time frame: 0-25 days
Assessment of clinical laboratory tests.
Time frame: 0-25 days
Assessment of vital signs (including blood pressure and pulse rate).
Time frame: 0-25 days
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Time frame: 0-25 days

20 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
Time frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose
Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
Time frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0- tau hours post dose
Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0- tau hours post dose
Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
Time frame: 0- tau 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 2 Mar 2016.
Derived from this study: PubMed 31776293Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520):eaav9701. doi: 10.1126/scitranslmed.aav9701.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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-06427878 in people with Healthy Subjects, run by Pfizer at 1 site in Belgium.

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 4 inclusion and 1 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 Mar 2016. 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 Belgium. 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?

Assessment of adverse events (AEs). (time frame: 0-25 days). 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 NCT02391623, which also lists 1 linked publication.

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 Mar 2016.