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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Gout

Treatments: Drug: PF-06743649; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187029

B7911002

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

PF-06743649 dose level 1 (Cohort 1)

Experimental group

Treatment:

Drug: PF-06743649

Drug: PF-06743649

Placebo for PF-06743649 (Cohort 1)

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo

PF-06743649 dose level 2 (Cohort 2)

Experimental group

Treatment:

Drug: PF-06743649

Drug: PF-06743649

Placebo for PF-06743649 (Cohort 2)

Placebo Comparator group

Treatment:

Other: Placebo

Other: Placebo