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

Gout Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02187029
• Other study ID #: B7911002
• Status: Terminated
• Phase: Phase 1
• First received: July 8, 2014
• Last updated: March 6, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• PF-06743649
Daily dosing (dose level 1) tablet for 14 days

Other:
• Placebo
Daily dosing (tablet) for 14 days

Drug:
• PF-06743649
Daily dosing (dose level 2) tablet(s) for 14 days

Other:
• Placebo
Daily dosing (tablets) for 14 days

Locations

Country	Name	City	State
United States	MRA Clinical Research, LLC	Miami	Florida
United States	Vince and Associates Clinical Research Inc.	Overland Park	Kansas
United States	Vince and Associates Clinical Research, Inc.	Overland Park	Kansas
United States	Miami Research Associates, Inc.	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum uric acid level	Serum uric acid level following 14 days of dosing	Baseline to 24 hours post-dose on Day 14	No
Secondary	Change from baseline in serum uric acid level	Serum uric acid level during 14 days of dosing	Baseline and at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up	No
Secondary	Serum uric acid levels	Proportion of subjects reaching serum uric acid levels <6, <5 and <4 mg/dL	Day 7 and Day 14	No
Secondary	Number of gout flare attacks	Number of gout flare attacks	Baseline to follow-up	Yes
Secondary	Severity of gout flare attacks	Severity of gout flare attacks	Baseline to follow-up	Yes
Secondary	Duration of gout flare attacks	Duration of gout flare attacks	Baseline to follow-up	Yes
Secondary	Plasma levels of PF-06743649	Plasma levels of PF-06743649 at 1, 7 and 14 days after initiation of dosing	1, 7 and 14 days after initiation of dosing	No
Secondary	Plasma levels of PF-06743648 (an active metabolite of PF-06743649)	Plasma levels of PF-06743648 at 1, 7 and 14 days after initiation of dosing	1, 7 and 14 days after initiation of dosing	No
Secondary	Plasma levels of xanthine	Plasma levels of xanthine at 1, 7 and 14 days after initiation of dosing and at follow-up	1, 7 and 14 days after initiation of dosing and at follow-up	No
Secondary	Plasma level of hypoxanthine	Plasma levels of xanthine at 1, 7 and 14 days after initiation of dosing and at follow-up	1, 7 and 14 days after initiation of dosing and at follow-up	No
Secondary	Urinary uric acid levels	Excretion of urinary uric acid	Baseline and at 1, 7 and 14 days after initiation of dosing	No
Secondary	Urinary xanthine levels	Excretion of urinary xanthine	Baseline and at 1, 7 and 14 days after initiation of dosing	No
Secondary	Urinary hypoxanthine levels	Excretion of urinary hypoxanthine	Baseline and at 1, 7 and 14 days after initiation of dosing	No

External Links

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