Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
A Phase 2, Randomized, Double-Blind, Dose-Ranging, Two-Part, Multi-Center Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
1 other identifier
interventional
99
1 country
24
Brief Summary
The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment, assessed on Day 22.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJanuary 23, 2012
January 1, 2012
1 year
September 25, 2009
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the effect of different doses of orally administered BCX4208 on serum uric acid (sUA)levels in subjects with gout.
Day 22
Study Arms (7)
40 mg
EXPERIMENTAL40 mg BCX4208
80 mg
EXPERIMENTALBCX4208
120 mg
EXPERIMENTALBCX4208
sugar pill
PLACEBO COMPARATOR160mg
EXPERIMENTALBCX4208
240mg
EXPERIMENTALBCX4208
320mg
EXPERIMENTALBCX4208
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18 to \<70 years
- Have read and signed the ICF after the nature of the study has been fully explained
- Screening sUA ≥8.0 mg/dL
- Diagnosis of gout according to the preliminary criteria of the American Rheumatism Association (1977)
- Female participants must meet at least one of the following specifications:
- Be surgically sterile
- Be post-menopausal as defined by:
- females ≥55 years of age whose last menstrual period \>1 year
- females between ≥45 and \<55 years of age whose last menstrual period \> 1 year and FSH \>40 mIU/mL and estradiol \<40 pg/mL
- Use oral contraceptives or some other form of hormonal birth control including hormonal vaginal rings or transdermal patches for 3 months prior to study drug dosing through 4 weeks after study drug administration
- Use an intrauterine device as birth control for 8 weeks prior to study drug dosing through 4 weeks after study drug administration
- Use (or ensure male partner\[s\]'s compliance with) a barrier contraception method (condom or diaphragm with a spermicide) for 4 weeks prior to study drug dosing through 4 weeks after study drug administration
- Male participants must be considered not of child-bearing potential defined as \>1 year post-vasectomy or use a condom for 4 weeks prior to study drug dosing through 4 weeks after study drug administration. In addition, they must ensure their sexual partner complies with the female contraception requirements specified above.
- Be willing to avoid procreation for 3 months after study drug administration.
- Be willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability policy.
You may not qualify if:
- Unstable angina
- History of cardiac arrhythmia
- History of congenital long QT
- Presence of cardiac signs or symptoms compatible with New York Heart Association Class III or Class IV functional status for congestive heart failure or angina
- Uncontrolled hypertension (above 150/95 mm Hg)
- History of moderate or severe renal impairment and/or previous clinical laboratory data indicating an estimated calculated creatinine clearance \< 60 mL/min during the previous 12 months
- ALT/AST values \>2.0 x ULN
- CD4+ cell counts by flow cytometry \<500 cells/mm3 or \>1600 cells/mm3
- Hemoglobin \<12 g/dL or \>17 g/dL (males) or \< 11 g/dL or \>16 g/dL (females)
- Hematocrit \<37% or \>51% (males) or \<33 % or \>47% (females)
- WBC \<3.7 x 109/L or \>11 X 109/L
- Immunocompromised due to illness or organ transplant
- Current use of systemic immunosuppressive medications or treatments
- Gout flare during the Screening Period that is resolved for less than 3 weeks prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis)
- Recipient of any live, attenuated vaccine within 6 weeks of Screening
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Radiant Research, Inc.
Scottsdale, Arizona, 85251, United States
Catalina Pointe Clinical Research
Tucson, Arizona, 85704, United States
Irvine Center for Clinical Research
Irvine, California, 92618, United States
San Diego Arthritis Medical Clinic
San Diego, California, 92108, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Anchor Research Center
Naples, Florida, 34102, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Selah Medical Center
Boise, Idaho, 83704, United States
Kentucky Medical Research Center
Lexington, Kentucky, 40504, United States
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Medex Healthcare Research
St Louis, Missouri, 63117, United States
Bozeman Urgent Care Center
Bozeman, Montana, 59715, United States
Heartland Clinical Research
Omaha, Nebraska, 68134, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
Triangle Medical Research Associates
Raleigh, North Carolina, 27609, United States
STAT Research
Dayton, Ohio, 45417, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Carolinas Center for Rheumatology & Arthritis
Rock Hill, South Carolina, 29732, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Renaissance Clinical Research
Dallas, Texas, 75235, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
January 23, 2012
Record last verified: 2012-01