GoutPhase 1NCT02187029

Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.

A Phase 1 study testing PF-06743649 in people with Gout, run by Pfizer at 4 sites in United States.

Terminated

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

Trial summary

The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Gout
What is being tested?: PF-06743649
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 4 sitesUnited States
Study dates: Jul 2014to Dec 2014
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of acute Arthritis of Primary Gout.
Subjects taking urate lowering therapy at the time of screening must be willing to discontinue their prior urate lowering therapy from the time of Screening Visit 1 until completion of the study period Day 16.
Subjects taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at time of the second screening visit.
Subjects NOT taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

Who cannot join

Positive medical history or current evidence of medical or psychiatric condition/disease, or ECG 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 subject inappropriate for entry into this study.
Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline, National Kidney Foundation)12; with GFR < 60 mL/min/1.73m2 calculated by the Cockcroft-Gault equation.
Subjects with current tophaceous gout.
Gout flare that has not resolved for at least 2 weeks prior to randomization.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

MRA Clinical Research, LLC
Miami, Florida, 33143
Vince and Associates Clinical Research Inc.
Overland Park, Kansas, 66211
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
Miami Research Associates, Inc.
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Third Party Open, Placebo Controlled Multi-center Study Of Efficacy, Safety And Tolerability Of Pf-06743649 In Gout Subjects

The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.

Conditions: Gout
Being tested: PF-06743649, Placebo
Keywords: Hyperuricemia, gout, serum uric acid
Medical subject headings: Gout, Hyperuricemia

What participants receive

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

PF-06743649Drug
Daily dosing (dose level 1) tablet for 14 days
PlaceboOther
Daily dosing (tablet) for 14 days
PF-06743649Drug
Daily dosing (dose level 2) tablet(s) for 14 days
PlaceboOther
Daily dosing (tablets) for 14 days

Study groups in NCT02187029
Study group	Role	What they receive
PF-06743649 dose level 1 (Cohort 1)	Experimental	Not described Receives: Drug: PF-06743649
Placebo for PF-06743649 (Cohort 1)	Placebo comparator	Not described Receives: Other: Placebo
PF-06743649 dose level 2 (Cohort 2)	Experimental	Not described Receives: Drug: PF-06743649
Placebo for PF-06743649 (Cohort 2)	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

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

Baseline of Serum Uric Acid
An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.
Measured: Baseline (pre-dose Day 1)
Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14
Measured: Day 14 Hour 24
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events.
Measured: Baseline up to 28 days after last study drug administration (Day 42)
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).
Measured: Baseline up to follow up visit (Day 25-29)
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).
Measured: Baseline up to follow up visit (Day 25-29)
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
Criteria for potential clinically important changes in ECG (12-lead) were defined as: 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) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval 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 from baseline.
Measured: Baseline up to Day 16

Secondary outcomes (11)

Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up
Measured: Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)
Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14
Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.
Measured: 24 hours post dose on Day 7 and Day 14
Incidence and Severity of Gout Flare Attacks
Measured: Baseline up to Day 42
Duration of Gout Flare Attacks
Duration of gout flare attacks with participants who developed gout flare attacks.
Measured: Baseline up to Day 42
Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14
Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).
Measured: 0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14
Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14
PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).
Measured: Day 1, Day 7, and Day 14
Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up
Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.
Measured: Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up
Measured: Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14
Change from baseline in urinary uric acid cumulative amounts.
Measured: Baseline, Day 1, Day 7 and Day 14
Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14
Change from baseline in urinary xanthine cumulative amounts.
Measured: Baseline, Day 1, Day 7 and Day 14
Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14
Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14
Measured: Baseline, Day 1, Day 7 and Day 14

Timeline

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

Jul 2014Dec 2014

First posted10 Jul 2014 (estimated)
Study startJul 2014
Primary completionDec 2014
Study completionDec 2014

Why it stopped: B7911002 was prematurely discontinued due to a safety concern that led to decision to terminate the study on 10 Nov 2014

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 GoutStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02187029
Sponsor's protocol ID: B7911002
Status last verified: Sep 2016
First submitted: 8 Jul 2014
Last updated: 11 Nov 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?

See locations

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Gout
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All Gout trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Third Party Open, Placebo Controlled Multi-center Study Of Efficacy, Safety And Tolerability Of Pf-06743649 In Gout Subjects
ClinicalTrials.gov ID: NCT02187029
Acronym / sponsor ID: B7911002
Conditions: Gout
Keywords: Hyperuricemia, gout, serum uric acid
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: B7911002 was prematurely discontinued due to a safety concern that led to decision to terminate the study on 10 Nov 2014
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Posted 11 Nov 2016

Clinical summary

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

The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
PF-06743649 dose level 1 (Cohort 1)	Experimental	Drug: PF-06743649
Placebo for PF-06743649 (Cohort 1)	Placebo comparator	Other: Placebo
PF-06743649 dose level 2 (Cohort 2)	Experimental	Drug: PF-06743649
Placebo for PF-06743649 (Cohort 2)	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of acute Arthritis of Primary Gout.
Subjects taking urate lowering therapy at the time of screening must be willing to discontinue their prior urate lowering therapy from the time of Screening Visit 1 until completion of the study period Day 16.
Subjects taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at time of the second screening visit.
Subjects NOT taking urate lowering therapy at the time of screening must have a serum urate level of >= 8.0 mg/dL at both screening visits 1 and 2.

Key exclusion criteria (4 listed)

Positive medical history or current evidence of medical or psychiatric condition/disease, or ECG 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 subject inappropriate for entry into this study.
Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline, National Kidney Foundation)12; with GFR < 60 mL/min/1.73m2 calculated by the Cockcroft-Gault equation.
Subjects with current tophaceous gout.
Gout flare that has not resolved for at least 2 weeks prior to randomization.

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-06743649Daily dosing (dose level 1) tablet for 14 days	Drug	PF-06743649 dose level 1 (Cohort 1)
PlaceboDaily dosing (tablet) for 14 days	Other	Placebo for PF-06743649 (Cohort 1)
PF-06743649Daily dosing (dose level 2) tablet(s) for 14 days	Drug	PF-06743649 dose level 2 (Cohort 2)
PlaceboDaily dosing (tablets) for 14 days	Other	Placebo for PF-06743649 (Cohort 2)

Primary outcome

Baseline of Serum Uric Acid
Time frame: Baseline (pre-dose Day 1)
An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.
Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14
Time frame: Day 14 Hour 24
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after last study drug administration (Day 42)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events.
Number of Participants With Laboratory Test Abnormalities
Time frame: Baseline up to follow up visit (Day 25-29)
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Time frame: Baseline up to follow up visit (Day 25-29)
Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
Time frame: Baseline up to Day 16
Criteria for potential clinically important changes in ECG (12-lead) were defined as: 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) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval 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 from baseline.

11 secondary outcomes

Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up
Time frame: Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)
Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14
Time frame: 24 hours post dose on Day 7 and Day 14
Incidence and Severity of Gout Flare Attacks
Time frame: Baseline up to Day 42
Duration of Gout Flare Attacks
Time frame: Baseline up to Day 42
Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14
Time frame: 0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14
Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14
Time frame: Day 1, Day 7, and Day 14
Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up
Time frame: Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up
Time frame: Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14
Time frame: Baseline, Day 1, Day 7 and Day 14
Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14
Time frame: Baseline, Day 1, Day 7 and Day 14
Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14
Time frame: Baseline, Day 1, Day 7 and Day 14

Results and safety

Results posted to the registry on 11 Nov 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
Cohort 1: PF-06743649 2.5 mg to 10 mg	7	6
Cohort 1: PF-06743649 40 mg	3	2
Cohort 2: PF-06743649 5 mg	11	0
Cohort 1 and 2: Placebo	9	6

Primary outcome: Baseline of Serum Uric Acid

Time frame: Baseline (pre-dose Day 1). Mean (Standard Deviation). Unit: milligram per deciliter(mg/dL)

Measure	Cohort 1: PF-06743649 2.5 mg to 10 mg n = 7	Cohort 1: PF-06743649 40 mg n = 3	Cohort 2: PF-06743649 5 mg n = 11	Cohort 1 and 2: Placebo n = 9
Value	8.800 (1.1402)	9.100 (0.8185)	8.991 (0.6549)	9.278 (0.9536)

Population analysed: The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.

Primary outcome: Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14

Time frame: Day 14 Hour 24. Mean (Standard Deviation). Unit: percent (%)

Measure	Cohort 1: PF-06743649 2.5 mg to 10 mg n = 6	Cohort 1: PF-06743649 40 mg n = 2	Cohort 2: PF-06743649 5 mg n = 0	Cohort 1 and 2: Placebo n = 6
Value	-52.891 (6.1661)	-67.480 (1.1498)	–	-1.381 (9.1430)

Cohort 1: PF-06743649 2.5 mg to 10 mg vs Cohort 1 and 2: Placebo: Mean Difference (Final Values): -52.550 (90% CI -56.320 to -48.780), Bayesian ANCOVA
Cohort 1: PF-06743649 40 mg vs Cohort 1 and 2: Placebo: Mean Difference (Final Values): -66.310 (90% CI -71.310 to -61.540), Bayesian ANCOVA

Population analysed: The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to "Cohort 2: PF-06743649 5 mg" termination after 2 days of dosing.

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to 28 days after last study drug administration (Day 42). Number. Unit: participants

Measure	Cohort 1: PF-06743649 2.5 mg to 10 mg n = 7	Cohort 1: PF-06743649 40 mg n = 3	Cohort 2: PF-06743649 5 mg n = 11	Cohort 1 and 2: Placebo n = 9
Participants with AEs	2	3	3	4
Participants with SAEs	0	0	1	0

Population analysed: The safety analysis population included all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Laboratory Test Abnormalities

Time frame: Baseline up to follow up visit (Day 25-29). Number. Unit: participants

Measure	Cohort 1: PF-06743649 2.5 mg to 10 mg n = 7	Cohort 1: PF-06743649 40 mg n = 3	Cohort 2: PF-06743649 5 mg n = 11	Cohort 1 and 2: Placebo n = 9
Value	1	1	3	2

Population analysed: The safety analysis population included all participants who received at least 1 dose of study medication.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 28 days after last study drug administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: PF-06743649 2.5 mg to 10 mg	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Cohort 1: PF-06743649 40 mg	0 of 3 (0%)	3 of 3 (100%)	Not reported
Cohort 2: PF-06743649 5 mg	1 of 11 (9.1%)	2 of 11 (18.2%)	Not reported
Cohort 1 and 2: Placebo	0 of 9 (0%)	4 of 9 (44.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 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

4 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-06743649 in people with Gout, run by Pfizer at 4 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 4 inclusion and 4 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 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. Some participants in this study may receive a placebo. 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 11 Nov 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?

Baseline of Serum Uric Acid (time frame: Baseline (pre-dose Day 1)). The study lists 6 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 NCT02187029.

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 11 Nov 2016.