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Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01416402
First received: August 11, 2011
Last updated: August 24, 2012
Last verified: October 2011
  Purpose

The purpose of this study is to determine whether arhalofenate is safe and effective when dosed in combination with febuxostat in lowering serum uric acid in patients with gout.


Condition Intervention Phase
Hyperuricemia
Gout
Drug: Arhalofenate
Drug: Febuxostat
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Arhalofenate (MBX-102) in Combination With Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

Resource links provided by NLM:


Further study details as provided by CymaBay Therapeutics, Inc.:

Primary Outcome Measures:
  • Proportion of patients achieving sUA <6.0 mg/dL, <5.0 mg/dL, <4.0 mg/dL and <3.0 mg/dL at the end of combination treatment period with each of the doses of arhalofenate [ Time Frame: 36 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arhalofenate with febuxostat Drug: Arhalofenate
400 mg once daily orally for two weeks then up-titrated to 600 mg once daily orally for an additional two weeks
Other Name: MBX-102
Drug: Febuxostat
80 mg once daily orally for 5 weeks
Other Name: Uloric

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Known gout patient (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout in Appendix 3) with a serum uric acid value of at least 8.0 mg/dL at Screening Visit. Patients on allopurinol must agree to discontinue their existing therapy at Visit 1 through the entire duration of the study and must have a sUA value of at least 8.0 mg/dL after a minimum 2 week wash-out at Visit 2.
  2. Male or female, 18-75 years of age at Screening Visit
  3. All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum FSH ≥ 40 mIU/mL) or must agree to use two medically accepted methods of contraception including a barrier method (see the list in Appendix 4) for the entire duration of the study unless report of complete sexual abstinence.
  4. Female patients must not be pregnant or lactating
  5. Male patients with a female partner of child-bearing potential must agree to use condom or the partner must use a medically acceptable method of contraception for the entire duration of the study.
  6. Estimated CrCl ≥ 50 mL/min as calculated by the by Cockcroft-Gault method
  7. Serum creatinine value must be ≤ 1.3 mg/dL in females and ≤ 1.4 mg/dL in males
  8. Patients must have liver function tests (LFTs) ≤ 1.5X ULN for AST, ALT and T-bilirubin, ≤ 2X ULN for ALP, ≤ 3X ULN for GGT; CK ≤ 3X ULN
  9. All other clinical laboratory parameters must be within normal limits or considered not clinically significant
  10. Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant
  11. Patients must have a systolic blood pressure ≤ 160 mm Hg and a diastolic blood pressure ≤ 95 mm Hg; known hypertensive patients controlled with medication other than diuretics (BP reading as above) may be included
  12. Patients must agree to remain in-clinic for 37 days consecutively and agree to follow the study procedures as described in the protocol

Exclusion Criteria:

  1. Treatment with any ULT other than allopurinol (e.g., probenecid, benzbromarone, febuxostat, or pegloticase) within two weeks of the Screening Visit
  2. Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant).
  3. Diagnosis of xanthinuria
  4. History of documented or suspected kidney stones
  5. Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
  6. History of illicit drug or alcohol abuse within one year of Screening Visit
  7. History of significant pulmonary disease, upper gastrointestinal (GI) bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), or nephrotic syndrome within three years of Screening Visit
  8. History of stroke, TIA, acute myocardial infarction (MI), congestive heart failure (CHF) (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within 5 years of screening
  9. Malignancy within five years of Screening Visit (except successfully treated basal cell carcinoma)
  10. Body mass index (BMI) > 42 kg/m2
  11. Current or expected requirement for anticoagulant therapy [except for low-dose (≤ 325 mg/day) aspirin and/or Plavix® 75 mg/day]
  12. Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
  13. Current or expected treatment with potent CYP3A4 inhibitors (See Appendix 6), cytotoxic agents (azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophyline, desipramine, sulphonylurea, thiazolidinedione, diuretics, atypical antipsychotic agents, or phenytoin
  14. Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs use to treat acute gout flares is permitted)
  15. Current or expected treatment with systemic corticosteroids (except topical, ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day) other than to treat acute gout flares
  16. Known hypersensitivity to colchicine or febuxostat
  17. Treatment with any other investigational therapy within the 30 days prior to the Screening Visit, or patients who received at least one dose of blinded study medication while enrolled in any previous arhalofenate trial
  18. Any other condition that compromises the ability of the patient to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the investigator and/or medical monitor
  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: NCT01416402

Locations
United States, Kansas
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
CymaBay Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01416402     History of Changes
Other Study ID Numbers: M102-21124
Study First Received: August 11, 2011
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CymaBay Therapeutics, Inc.:
Hyperuricemia
gout
serum uric acid

Additional relevant MeSH terms:
Gout
Hyperuricemia
Arthritis
Genetic Diseases, Inborn
Joint Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Musculoskeletal Diseases
Pathologic Processes
Purine-Pyrimidine Metabolism, Inborn Errors
Rheumatic Diseases
Febuxostat
Antirheumatic Agents
Gout Suppressants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014