Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00985127
First received: September 25, 2009
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Gout
Drug: placebo
Drug: BCX4208
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioCryst Pharmaceuticals:

Primary Outcome Measures:
  • To determine the effect of different doses of orally administered BCX4208 on serum uric acid (sUA)levels in subjects with gout. [ Time Frame: Day 22 ] [ Designated as safety issue: Yes ]

Enrollment: 99
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg
40 mg BCX4208
Drug: BCX4208
Administered daily for 21 days.
Experimental: 80 mg
BCX4208
Drug: BCX4208
Administered daily for 21 days.
Experimental: 120 mg
BCX4208
Drug: BCX4208
Administered daily for 21 days.
Placebo Comparator: sugar pill Drug: placebo
administered daily for 21 days
Experimental: 160mg
BCX4208
Drug: BCX4208
Administered daily for 21 days.
Experimental: 240mg
BCX4208
Drug: BCX4208
Administered daily for 21 days.
Experimental: 320mg
BCX4208
Drug: BCX4208
Administered daily for 21 days.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 to <70 years
  2. Have read and signed the ICF after the nature of the study has been fully explained
  3. Screening sUA ≥8.0 mg/dL
  4. Diagnosis of gout according to the preliminary criteria of the American Rheumatism Association (1977)
  5. 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
  6. 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.
  7. Be willing to avoid procreation for 3 months after study drug administration.
  8. 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.

Exclusion Criteria:

  1. Unstable angina
  2. History of cardiac arrhythmia
  3. History of congenital long QT
  4. 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
  5. Uncontrolled hypertension (above 150/95 mm Hg)
  6. 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
  7. ALT/AST values >2.0 x ULN
  8. CD4+ cell counts by flow cytometry <500 cells/mm3 or >1600 cells/mm3
  9. Hemoglobin <12 g/dL or >17 g/dL (males) or < 11 g/dL or >16 g/dL (females)
  10. Hematocrit <37% or >51% (males) or <33 % or >47% (females)
  11. WBC <3.7 x 109/L or >11 X 109/L
  12. Immunocompromised due to illness or organ transplant
  13. Current use of systemic immunosuppressive medications or treatments
  14. 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)
  15. Recipient of any live, attenuated vaccine within 6 weeks of Screening
  16. History of clinically significant and relevant drug and/or food allergies
  17. History of chronic or recurrent infections
  18. History of any type of cancer (hematologic or solid tumor), that has required chemotherapy or radiation therapy in the previous 12 months, excluding non-melanomatous localized skin cancer
  19. Use of uric acid-lowering drugs within 30 days prior to the first dose of study drug or other prohibited medications within the timeframes specified in the protocol
  20. ACTH administration within 30 days of first treatment with study drug
  21. Intra-articular corticosteroid administration within 30 days of first treatment with study drug
  22. Systemic or oral glucocorticosteroid use within 4 weeks of first treatment with study drug or for a period of ≥ 6 months out of the last 12 months prior to the first treatment with study drug
  23. History of alcohol or drug abuse within the year prior to the signing of the ICF, or current evidence of substance dependence or abuse (alcohol intake > 3 drinks per day)
  24. Female subjects who are pregnant, planning a pregnancy or breastfeeding
  25. Positive pregnancy test
  26. Positive serology for hepatitis B or C surface antigen or human immunodeficiency virus (HIV) type 1
  27. Have been the recipient of any investigational drug within the last 30 days prior to the first treatment with study drug
  28. Other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985127

  Show 24 Study Locations
Sponsors and Collaborators
BioCryst Pharmaceuticals
  More Information

No publications provided

Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00985127     History of Changes
Other Study ID Numbers: BCX4208-201
Study First Received: September 25, 2009
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioCryst Pharmaceuticals:
Hyperuricemia
Gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014