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

NCT01129648 | Completed Phase 2

• 1 other identifier: BCX4208-202
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Gout

Keywords

Hyperuricemia, gout

Outcome Measures

Primary Outcomes (1)

• To estimate the dose response relationship of BCX4208 when administered as a monotherapy and in combination with allopurinol on sUA.

  Day 22

Study Arms (16)

BCX4208 placebo + Allopurinol placebo

PLACEBO COMPARATOR

Administered daily for 21 days.

Drug: Placebo

BCX4208 placebo + Allopurinol 100mg

ACTIVE COMPARATOR

Administered daily for 21 days.

Drug: Allopurinol

BCX4208 placebo + Allopurinol 200 mg

ACTIVE COMPARATOR

Administered daily for 21 days.

Drug: Allopurinol

BCX4208 Placebo + Allopurinol 300 mg

ACTIVE COMPARATOR

Administered daily for 21 days.

Drug: Allopurinol

BCX4208 20 mg + Allopurinol Placebo

EXPERIMENTAL

Administered daily for 21 days.

Drug: BCX4208

BCX4208 20 mg + Allopurinol 100 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 20 mg + Allopurinol 200 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 20 mg + Allopurinol 300 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 40 mg + Allopurinol placebo

EXPERIMENTAL

Administered daily for 21 days.

Drug: BCX4208

BCX4208 40 mg + Allopurinol 100 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 40 mg + Allopurinol 200 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 40 mg + Allopurinol 300 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 80 mg + Allopurinol Placebo

EXPERIMENTAL

Administered daily for 21 days.

Drug: BCX4208

BCX4208 80 mg + Allopurinol 100 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 80 mg + Allopurinol 200 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

BCX4208 80 mg + Allopurinol 300 mg

EXPERIMENTAL

Administered daily for 21 days.

Drug: Allopurinol; Drug: BCX4208

Interventions

Placebo DRUG

Administered daily for 21 days

BCX4208 placebo + Allopurinol placebo

Allopurinol DRUG

Administered daily for 21 days.

BCX4208 placebo + Allopurinol 100mg

BCX4208 DRUG

Administered daily for 21 days.

BCX4208 20 mg + Allopurinol Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (18)

Unknown Facility

Scottsdale, Arizona, 85251, United States

Location

Unknown Facility

Irvine, California, 92618, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Honolulu, Hawaii, 96814, United States

Location

Unknown Facility

Boise, Idaho, 83704, United States

Location

Unknown Facility

Lexington, Kentucky, 40504, United States

Location

Unknown Facility

Frederick, Maryland, 21702, United States

Location

Unknown Facility

Olive Branch, Mississippi, 38654, United States

Location

Unknown Facility

Billings, Montana, 59107, United States

Location

Unknown Facility

Omaha, Nebraska, 68134, United States

Location

Unknown Facility

Reno, Nevada, 89502, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Charlotte, North Carolina, 28211, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Rapid City, South Dakota, 57702, United States

Location

Unknown Facility

Bristol, Tennessee, 37620, United States

Location

Unknown Facility

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Allopurinol; ulodesine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 25, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

US (18)