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Keep this study
Lead
BioCryst Pharmaceuticals
Age
18–69
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 to \< 70 years
Baseline sUA ≥ 6.0 mg/dL after at least 2 weeks of treatment on a stable 300 mg dose of allopurinol
Documented diagnosis of gout according to the American Rheumatism Association --Preliminary Criteria for the Diagnosis of Gout
Be willing and able to take colchicine 0.6 mg per day or naproxen 220-250 mg twice daily as prophylaxis for gout flares and, if needed, a single daily dose of a proton pump inhibitor to prevent gastrointestinal discomfort
Female participants must:
* Be sexually abstinent
* Be surgically sterile
* Be postmenopausal or on stable contraception
Male participants must:
* Be sexually abstinent
* Be \> 1 year post-vasectomy
* Using condoms with spermicide with partners meeting female requirements
You may not be if
Unable to tolerate 300 mg allopurinol
Unable to tolerate both colchicine 0.6 mg per day and naproxen 220-250 mg twice daily
Prior participation in a clinical study with BCX4208
Gout flare during the Screening Period that is resolved for less than 2 weeks prior to first treatment with BCX4208 or placebo (exclusive of chronic synovitis/ arthritis)
Unstable angina, symptomatic arrhythmia, signs or symptoms compatible with New York Heart Association Class III or Class IV heart failure, history of long QT syndrome, or QTc interval \< 350 msec or \> 475 msec
Poorly controlled hypertension (SBP \> 160 mmHg or DBP \> 100 mmHG at Screening or Baseline)
Moderate or severe renal impairment and/or calculated creatinine clearance of \< 60 mL/min(Cockroft-Gault method)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \> 2.0 x ULN
CD4+ cell counts by flow cytometry \< 500 cells/mm3
Hemoglobin \< 10 g/dL or \> 18 g/dL males or \< 10 g/dL or \> 17 g/dL females White blood cell count \< 3.7 x 109/L or \> 11 x 109/L
Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the next 4 months
Positive serology for hepatitis B surface antigen or hepatitis C or HIV type 1
Immunocompromised or on systemic immunosuppressive medications or antirheumatic drugs (including anakinra and adrenocorticotropic hormone)from Screening to Day 92
Azathioprine or 6-mercaptopurine within 14 days of first dose of allopurinol Hydrochlorothiazide in doses \> 50 mg per day from Screening to Day 92
Use of herbal/dietary supplements Screening to Day 92
Recipient of any live or attenuated vaccine within 6 weeks of Screening
Uric acid-lowering drugs other than allopurinol from Screening to Day 92 Systemic corticosteroids within 4 weeks prior to Day 1 (this does not include pulmonary or nasal inhaler containing corticosteroids, ophthalmic corticosteroids, joint injections, or low potency topical steroids)
Investigational drug within 30 days prior to signing the ICF for this study
Clinically significant and relevant drug allergies
Chronic or recurrent infections (≥ 3 infections at the same site within 12 months)
Cancer within 12 months-Except non-melanomatous localized skin cancer or completely excised and cured carcinoma-in-situ of uterine cervix or subjects who were previously treated for prostate or breast cancer if they currently are stable and have not been on chemo therapy within the last year prior to screening.
Alcohol or drug abuse within 12 months of signing the ICF, or current substance dependence or abuse
Other medical conditions which, in the opinion of the PI, would jeopardize the safety of the study subject or impact the validity of the study results.
Clareo Health | Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol
