Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout

Completed · Phase 2 · Has a placebo group

Conditions studied: Gout

In brief

To evaluate safety and efficacy of BCX4208 alone and in combination with allopurinol in subjects with gout.

Key facts

Study ID

NCT01129648

Run by

BioCryst Pharmaceuticals

People needed

87

Starts

2010-05-01

Expected to finish

2010-11-01

Last updated by the study team

2012-01-23

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 to <70 years, with screening sUA > 8.0 mg/dL.
• Diagnosis of gout according to the criteria of the American Rheumatism Association (1977).
• Be willing and able to take colchicine 0.6 mg per day or naproxen 250 mg twice daily (with proton pump inhibitor if needed) as prophylaxis for gout flares.
• Be willing to abstain from blood donations from Day -14 to Day 29/Early Termination.
• Female participants must be sexually abstinent, sterile, post-menopausal, or on stable contraception.
• Post-menopausal - females greater ≥ 45 years of age whose last menstrual period, including spotting, was > 1 year ago.
• Stable contraception - now requires a double barrier method, e.g. condom or diaphragm with spermicide.
• Male participants must be abstinent, vasectomized or using condoms with spermicide with partners meeting female requirements.

You may not qualify if…

• Unable to tolerate allopurinol.
• Gout Flare during Screening Period that is resolved less than 2 weeks prior to first treatment.
• Unstable angina, history of symptomatic arrhythmia, or Class III or IV heart failure.
• ECG Findings: history of congenital long QT syndrome; QTc interval < 350 msec or > 475 msec.
• Inadequately controlled hypertension (above either or both 150/95 mm Hg).
• Moderate or severe renal impairment and/or calculated creatinine clearance <60 mL/min (using Cockcroft-Gault formula).
• ALT or AST > 2.0 x ULN.
• CD4+ count by flow cytometry (<500 cells/mm3).
• Hgb <12 g/dL or > 17 g/dL (males) or < 11 g/dL or > 16 g/dL (females).
• Hct < 37% or > 51% (males) < 33% or > 47% (females).
• WBC < 3.7 x 109/L or > 11 x 109/L.
• Positive Pregnancy Test.
• Females who are pregnant, breastfeeding or planning a pregnancy with the next 4 months.
• Positive serology for hepatitis B surface antigen or hepatitis C or HIV type I (HIV Ab).
• Immunocompromised or on systemic immunosuppressant medications (including anakinra) within 14 days of study dosing.
• Use of azathioprine or 6-mercatopurine within 14 days of study dosing.
• Use of HCTZ in doses > 50mg per day within 14 days of study dosing.
• Recipient of any live, attenuated vaccine within 6 weeks of Screening.
• Receipt of sUA-lowering drugs, ACTH, within 14 days of study dosing.
• Use of systemic corticosteroids within 4 weeks prior to study dosing.
• Clinically significant and relevant drug allergies.
• Chronic or recurrent infections (3 infections at same site) within 12 months.
• Cancer within 12 months (except nonmelanomatous localized skin cancer.
• Alcohol or drug abuse.
• Investigational drug within 30 days of study dosing.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Irvine, California, United States
• Study site — South Miami, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Boise, Idaho, United States
• Study site — Lexington, Kentucky, United States
• Study site — Frederick, Maryland, United States
• Study site — Olive Branch, Mississippi, United States
• Study site — Billings, Montana, United States
• Study site — Omaha, Nebraska, United States
• Study site — Reno, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Bristol, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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