Clinical trial NCT02187029: Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Gout
Keywords: Hyperuricemia
gout
serum uric acid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Baseline of Serum Uric Acid
timeFrame: Baseline (pre-dose Day 1)
measure: Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14
timeFrame: Day 14 Hour 24
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last study drug administration (Day 42)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to follow up visit (Day 25-29)
measure: Number of Participants With Potentially Clinically Significant Vital Signs Findings
timeFrame: Baseline up to follow up visit (Day 25-29)
measure: Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
timeFrame: Baseline up to Day 16
Secondary outcomes:
measure: Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up
timeFrame: Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)
measure: 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
timeFrame: 24 hours post dose on Day 7 and Day 14
measure: Incidence and Severity of Gout Flare Attacks
timeFrame: Baseline up to Day 42
measure: Duration of Gout Flare Attacks
timeFrame: Baseline up to Day 42
measure: Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14
timeFrame: 0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14
measure: Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14
timeFrame: Day 1, Day 7, and Day 14
measure: Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up
timeFrame: Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
measure: Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up
timeFrame: Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
measure: Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14
timeFrame: Baseline, Day 1, Day 7 and Day 14
measure: Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14
timeFrame: Baseline, Day 1, Day 7 and Day 14
measure: Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14
timeFrame: Baseline, Day 1, Day 7 and Day 14
Other outcomes:
Locations:
city: Miami
country: United States
facility: MRA Clinical Research, LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates, Inc.
state: Florida
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research Inc.
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, Inc.
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: