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

NCT01336686 | Completed Phase 2

• 1 other identifier: M102-21122
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 12

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.

Conditions

Hyperuricemia; Gout

Outcome Measures

Primary Outcomes (1)

• Serum uric acid

  Baseline and end of treatment phase (4 wks)

Study Arms (3)

Arhalofenate 400 mg

EXPERIMENTAL

Drug: Arhalofenate; Drug: Colchicine

Arhalofenate 600 mg

EXPERIMENTAL

Drug: Arhalofenate; Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Drug: Placebo comparator; Drug: Colchicine

Interventions

Arhalofenate DRUG

Arhalofenate 400 mg once daily for 4 weeks

Also known as: MBX-102

Arhalofenate 400 mg

Placebo comparator DRUG

Matching placebo once daily for 4 weeks

Placebo

Colchicine DRUG

0.6 mg colchicine daily for flare prophylaxis

Arhalofenate 400 mg; Arhalofenate 600 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (12)

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Boca Raton, Florida, United States

Location

Unknown Facility

Jupiter, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Honolulu, Hawaii, United States

Location

Unknown Facility

Wheaton, Maryland, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

West Jordan, Utah, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

arhalofenate; Colchicine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Alkaloids; 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 18, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 17, 2015

Record last verified: 2015-03

Locations

US (12)