HealthyPhase 1POMNCT01965600

A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model

A Phase 1 study testing PF-06282999 and LPS in people with Healthy, run by Pfizer at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

An endotoxin challenge will be administered to healthy subjects to induce production of inflammatory markers. An investigational drug or placebo will be administered prior to the endotoxin challenge to assess the effect of the investigational drug on the markers of inflammation. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PF-06282999 and LPS
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: Mar 2014to Feb 2015
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men or women (non-childbearing potential) between the ages of 18-40 years.
Body Mass Index (BMI) 18-30 kg/m2 and a total body weight >50 kg (110 lbs).

Who cannot join

History or evidence of habitual use of tobacco- or nicotine-containing products within 3 months of screening.
History of frequent headaches or migraines (>3 per month), or headaches from an absence of caffeine.
Caffeine consumption in excess of 3 cups per day.
Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks of the first administration of study drug/placebo of each period.
History of recurrent or chronic infections of any type such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc. Also excluded are subjects with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for worsening if enrolled in this study.
Treatment with LPS in the past 12 months and/or a history of an allergic type reaction or known hypersensitivity to endotoxin at any time.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

(Drug Shipment Address ONLY) Duke University Health Systems (DUHS) Investigational Drug Services
Durham, North Carolina, 27710
Duke Clinical Research Unit
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose, 2 Way Crossover Study To Evaluate The Safety And Pharmacodynamic Effects Of Pf 06282999 Using An Endotoxin (Lipopolysaccharide) Induced Inflammatory Response Model In Healthy Adult Subjects

Read the detailed description

The trial was terminated on 25 March 2015 due to safety concerns regarding the administration of endotoxin and because of the uncertain availability of future endotoxin lots.

Conditions: Healthy
Being tested: PF-06282999, Placebo, LPS
Keywords: Endotoxin challenge

What participants receive

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

PF-06282999Drug
Tablet, 125 mg, TID, 3 days, 1 of 2 periods
PlaceboDrug
Tablet, 0 mg, TID, 3 days, 1 of 2 periods
LPSOther
Also called Endotoxin
IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods
PF-06282999Drug
Tablet, 500 mg, BID, 3 days, 1 of 2 periods
PlaceboDrug
Tablet, 0 mg, BID, 3 days, 1 of 2 periods
LPSOther
Also called Endotoxin
IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods

Study groups in NCT01965600
Study group	Role	What they receive
Cohort 1	Experimental	Not described Receives: Drug: PF-06282999; Drug: Placebo; Other: LPS
Cohort 2	Experimental	Not described Receives: Drug: PF-06282999; Drug: Placebo; Other: LPS

What is being measured

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

Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Measured: Days 1, 3-5
MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Measured: Days 1, 3-5
MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Measured: Days 1, 3-5
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Measured: From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Measured: Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change (increase [inc] or decrease [dec]) in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate (PR) of <40 or more than (>)120 beats per minute (bpm); and standing PR of <40 or >140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Measured: Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurements
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval >=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec, and >=500 msec, or an increase of 30 to <60 msec or >=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Measured: Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2
Number of Participants With Abnormal Urinary Biomarker Values
Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.
Measured: Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5

Secondary outcomes (5)

Concentrations of TNF-alpha, IL-1 Beta, IL-6, IL-8, and hsCRP
The effect of multiple oral doses of PF-06282999 on inflammatory biomarkers was a secondary objective in this study. The biomarkers are tumor necrosis factor (TNF)-alpha, interleukin (IL)-1 beta, IL-6, IL-8, and high-sensitivity C-reactive protein (hsCRP).
Measured: Days 1, 3, and 4
Peak (AUC0.5-2hours and AUC0-2hours) of MPO Activity/MPO Mass
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Measured: Days 1, 3-5
Maximum Plasma Concentration (Cmax) of PF-06282999
Measured: Day 3
Area Under the Concentration-time Profile From Time 0 to End of Dosing Interval, Tau (AUCtau) of PF-06282999
Measured: Day 3
Time to Cmax (Tmax) of PF-06282999
Measured: Day 3

Timeline

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

Mar 2014Feb 2015

First posted18 Oct 2013 (estimated)
Study startMar 2014
Primary completionFeb 2015
Study completionFeb 2015

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 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01965600
Sponsor's protocol ID: B5211007
Other IDs: 2013-001528-20
Acronym: POM
Status last verified: Jun 2016
First submitted: 15 Oct 2013
Last updated: 2 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose, 2 Way Crossover Study To Evaluate The Safety And Pharmacodynamic Effects Of Pf 06282999 Using An Endotoxin (Lipopolysaccharide) Induced Inflammatory Response Model In Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01965600
Acronym / sponsor ID: POM / B5211007
Conditions: Healthy
Keywords: Endotoxin challenge
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 23 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 18 Oct 2013 (estimated)
Results: Posted 2 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The trial was terminated on 25 March 2015 due to safety concerns regarding the administration of endotoxin and because of the uncertain availability of future endotoxin lots.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: PF-06282999, Drug: Placebo, Other: LPS
Cohort 2	Experimental	Drug: PF-06282999, Drug: Placebo, Other: LPS

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy men or women (non-childbearing potential) between the ages of 18-40 years.
Body Mass Index (BMI) 18-30 kg/m2 and a total body weight >50 kg (110 lbs).

Key exclusion criteria (6 listed)

History or evidence of habitual use of tobacco- or nicotine-containing products within 3 months of screening.
History of frequent headaches or migraines (>3 per month), or headaches from an absence of caffeine.
Caffeine consumption in excess of 3 cups per day.
Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks of the first administration of study drug/placebo of each period.
History of recurrent or chronic infections of any type such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc. Also excluded are subjects with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for worsening if enrolled in this study.

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-06282999Tablet, 125 mg, TID, 3 days, 1 of 2 periods	Drug	Cohort 1
PlaceboTablet, 0 mg, TID, 3 days, 1 of 2 periods	Drug	Cohort 1
LPSAlso: EndotoxinIV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods	Other	Cohort 1
PF-06282999Tablet, 500 mg, BID, 3 days, 1 of 2 periods	Drug	Cohort 2
PlaceboTablet, 0 mg, BID, 3 days, 1 of 2 periods	Drug	Cohort 2
LPSAlso: EndotoxinIV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods	Other	Cohort 2

Primary outcome

Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus
Time frame: Days 1, 3-5
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus
Time frame: Days 1, 3-5
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus
Time frame: Days 1, 3-5
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Time frame: From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Number of Participants With Laboratory Test Abnormalities
Time frame: Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Time frame: Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurements
Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change (increase [inc] or decrease [dec]) in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate (PR) of <40 or more than (>)120 beats per minute (bpm); and standing PR of <40 or >140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
Time frame: Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2
Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval >=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec, and >=500 msec, or an increase of 30 to <60 msec or >=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Number of Participants With Abnormal Urinary Biomarker Values
Time frame: Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5
Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.

5 secondary outcomes

Concentrations of TNF-alpha, IL-1 Beta, IL-6, IL-8, and hsCRP
Time frame: Days 1, 3, and 4
Peak (AUC0.5-2hours and AUC0-2hours) of MPO Activity/MPO Mass
Time frame: Days 1, 3-5
Maximum Plasma Concentration (Cmax) of PF-06282999
Time frame: Day 3
Area Under the Concentration-time Profile From Time 0 to End of Dosing Interval, Tau (AUCtau) of PF-06282999
Time frame: Day 3
Time to Cmax (Tmax) of PF-06282999
Time frame: Day 3

Results and safety

Results posted to the registry on 2 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-06282999 125 mg TID Followed by Placebo	6	6
Placebo Followed by PF-06282999 125 mg TID	8	8
PF-06282999 500 mg BID Followed by Placebo	5	5
Placebo Followed by PF-06282999 500 mg BID	4	4

Primary outcome: Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus

Time frame: Days 1, 3-5

Population analysed: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.

Primary outcome: MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus

Time frame: Days 1, 3-5

Population analysed: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.

Primary outcome: MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus

Time frame: Days 1, 3-5

Population analysed: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs

Time frame: From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months). Number. Unit: participants

Measure	PF-06282999 125 mg TID n = 10	Placebo n = 19	PF-06282999 500 mg BID n = 7
Participants with TEAEs	10	17	5
Participants with SAEs	0	0	0
Participants discontinued permanently due to TEAEs	0	1	0

Population analysed: All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-06282999 125 mg TID	0 of 10 (0%)	10 of 10 (100%)	Not reported
Placebo	0 of 19 (0%)	17 of 19 (89.5%)	Not reported
PF-06282999 500 mg BID	0 of 7 (0%)	5 of 7 (71.4%)	Not reported

Limitations and caveats (from the sponsor): Due to early study termination, PK, PD, or biomarker changes assessments were incomplete and there was only safety data from partial enrollment. As such, it was not possible to have meaningful interpretation and/or comparison of these data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

2 sites 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-06282999 and LPS in people with Healthy, run by Pfizer at 2 sites 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 2 Aug 2016). 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?

Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus (time frame: Days 1, 3-5). 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 NCT01965600.

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 Aug 2016.