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Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336686
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : April 17, 2015
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Brief Summary:
The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.

Condition or disease Intervention/treatment Phase
Hyperuricemia Gout Drug: Arhalofenate Drug: Placebo comparator Drug: Colchicine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in the Treatment of Hyperuricemia in Patients With Gout
Study Start Date : May 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Arhalofenate 400 mg Drug: Arhalofenate
Arhalofenate 400 mg once daily for 4 weeks
Other Name: MBX-102

Drug: Colchicine
0.6 mg colchicine daily for flare prophylaxis

Experimental: Arhalofenate 600 mg Drug: Arhalofenate
Arhalofenate 600 mg once daily for 4 weeks
Other Name: MBX-102

Drug: Colchicine
0.6 mg colchicine daily for flare prophylaxis

Placebo Comparator: Placebo Drug: Placebo comparator
Matching placebo once daily for 4 weeks

Drug: Colchicine
0.6 mg colchicine daily for flare prophylaxis

Primary Outcome Measures :
  1. Serum uric acid [ Time Frame: Baseline and end of treatment phase (4 wks) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Read and sign the informed consent after the elements of consent have been fully explained and all questions have been addressed, prior to any study procedures.
  • Known gout patient (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout in Appendix 3)

    • the sUA must be ≥ 8.0 mg/dL and ≤12 mg/dL
    • if on ULT, the patients must agree to temporarily discontinue their existing ULT and the sUA must be ≥ 8.0 mg/dL and ≤12 mg/dL after wash-out at Week -1
  • Male or female, 18-75 years of age at Screening Visit
  • 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 have a partner who has undergone vasectomy 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 reporting complete sexual abstinence.
  • Female patients must not be pregnant or lactating
  • 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.
  • Patients must have an estimated CrCl ≥ 60 mL/min as calculated by the Cockcroft-Gault method
  • Serum creatinine value must be ≤ 1.1 mg/dL in females and ≤ 1.3 mg/dL in males
  • Patients must have liver function tests ≤ 1.5X ULN for AST, ALT and T-bilirubin, ≤ 2X ULN for ALP, ≤ 3X ULN for GGT; and ≤ 3X ULN for CK
  • All other clinical laboratory parameters must be within normal limits or considered not clinically significant for participation in this study
  • Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant for participation in this study
  • Patients must have a systolic blood pressure ≤ 160 mm Hg and a diastolic blood pressure ≤ 90 mm Hg; known hypertensive patients controlled with medication other than thiazide diuretics (BP reading as above) may be included

Exclusion Criteria:

  • Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant).
  • Known patient with xanthinuria
  • History of documented or suspected kidney stones
  • Over producers of uric acid as evidenced by 24-hour urinary uric acid > 800 mg (on normal unrestricted diet)
  • Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
  • History of illicit drug or alcohol abuse within last 1 year
  • History of significant pulmonary disease, upper GI bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), or nephrotic syndrome within last 3 years
  • All patients must not have had a stroke, TIA, acute myocardial infarction, congestive heart failure (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 last 5 years
  • Malignancy within the last 5 years (except resected basal cell carcinoma)
  • Body mass index (BMI) > 42 kg/m2
  • Current or expected requirement for anticoagulant therapy (except for ≤ 325 mg/day aspirin and/or Plavix® 75 mg/day)
  • Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
  • Current or expected treatment with potent CYP3A4 inhibitors (See in Appendix 6), ranolazine, digoxin, cyclosporine, cyclophosphamide and other cytotoxic agents, sulphonylurea, thiazolidinedione, diuretic, atypical antipsychotic agents, and phenytoin
  • Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs use to treat acute flares are permitted)
  • 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 flares
  • Known hypersensitivity to colchicine
  • 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 drug while enrolled in any previous MBX-102 trial
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01336686

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United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
United States, Florida
Boca Raton, Florida, United States
Jupiter, Florida, United States
Tampa, Florida, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Maryland
Wheaton, Maryland, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
New York, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Utah
West Jordan, Utah, United States
Sponsors and Collaborators
CymaBay Therapeutics, Inc.
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Responsible Party: CymaBay Therapeutics, Inc. Identifier: NCT01336686    
Other Study ID Numbers: M102-21122
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents