GoutPhase 2NCT02252835
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
A Phase 2 study testing Arhalofenate, Febuxostat and Colchicine in people with Gout and Hyperuricemia, run by Gilead Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Arhalofenate, Febuxostat and Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2014
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient, 18 to 75 years of age, inclusive
- Known gout diagnosis (per criteria of the American Rheumatism Association)
- Has an sUA ≥ 7.5 mg/dL
- A female patient must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least two years), or must agree to use two medically accepted methods of contraception including a barrier method for the entire duration of study participation unless she reports compete sexual abstinence. A female patient must also not be pregnant or lactating
- Estimated creatinine clearance (eCrCl) ≥ 60 ml/min, as calculated by Cockcroft-Gault method
- ALT or AST ≤ 3 times upper limit of normal (ULN) or total bilirubin ≤ 2 times ULN (Gilbert's syndrome is permitted)
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- All other clinical laboratory parameters must be within normal limits or considered not clinically significant
- ECG must be normal, or if abnormal, considered not clinically significant
- A patient who is taking a medication or agent (other than a ULT) known to influence sUA levels must be on a stable dose and regimen of the medication for at least two weeks prior to screening and must be willing to continue the same dose and regimen during study participation
- Expected to be able to tolerate a short course of oral NSAIDs and/or oral steroids as may be needed to treat a gout flare
- Must be able to swallow tablets
Who cannot join
- Treatment with any ULT (e.g., allopurinol, febuxostat, probenecid, or benzbromarone) within two weeks, or pegloticase within six months, prior to the sUA assessment at Day 1
- Occurrence of a gout flare that has not resolved within one week prior to Day 1
- Known or suspected secondary hyperuricemia (e.g., due to myeloproliferative disorder or organ transplant)
- Diagnosis of xanthinuria
- Fractional excretion of urate > 10%
- History of documented or suspected kidney stones within five years prior to screening
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- Known infection with the human immunodeficiency virus (HIV) or history of hepatitis B or C
- Recent use/abuse of an illicit drug as determined by a positive urine drug screen
- Uncontrolled hypertension that, in the opinion of the Investigator, would preclude participation in the study
- History of stroke, transient ischemic attack, acute myocardial infarction, congestive heart failure (NYHA class II - IV), angina pectoris, coronary intervention procedure, lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within 5 years of screening
- History of cancer within five years of screening, with the following exceptions: adequately treated non-melanoma skin cancer, non-metastatic prostate cancer, or in situ cervical cancer
- Body mass index (BMI) > 42 kg/m2
- Current or expected requirement for anticoagulant therapy, except for low dose (≤ 81 mg/day) aspirin, clopidogrel (Plavix) ≤ 75 mg/day, or prasugrel (Effient) ≤ 10 mg/day
- Use of any of the following within eight weeks prior to screening: potent CYP3A4 inhibitors, cytotoxic agents (including azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones (e.g., rosiglitazone or pioglitazone), desipramine, atypical antipsychotic agents, loop diuretics, warfarin, or phenytoin
- Chronic treatment with NSAIDs that cannot be safely discontinued-term use of NSAIDs is permitted, e.g., when used to treat gout flares
- Known hypersensitivity or intolerance to febuxostat or colchicine
- Treatment with any other investigational therapy within 30 days or within five half-lives, whichever is longer prior to Day 1
- Any other condition that would compromise the safety of the patient, prevent compliance with the study protocol, or compromise the quality of the clinical study, as judged by the Investigator and/or Medical Monitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 2, Open-label, Drug-Drug Interaction Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination With Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.
Read the detailed description
Patients entering the six-week Treatment Period will receive once daily oral dosing of arhalofenate during Weeks 1 and 2 (Days 1 through 14), combined once daily oral dosing of arhalofenate and febuxostat during Weeks 3 and 4 (Days 15 through 28), and once daily oral dosing of febuxostat during Weeks 5 and 6 (Days 29 through 42). In addition, all patients will receive once daily oral dosing of colchicine throughout the Treatment Period.
- Conditions
- Gout, Hyperuricemia
- Being tested
- Arhalofenate, Febuxostat, Colchicine
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArhalofenateDrug
800 mg once daily orally for four weeks
FebuxostatDrug
40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks
ArhalofenateDrug
600 mg once daily orally for four weeks
FebuxostatDrug
80 mg once daily orally for 1 week then down-titrated to 40 mg once daily orally for another three weeks
ColchicineDrug
0.6 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Arhalofenate with febuxostat (PK cohort) | Experimental | Not described Receives: Drug: Arhalofenate; Drug: Febuxostat; Drug: Colchicine |
| Arhalofenate with febuxostat (non-PK cohort) | Experimental | Not described Receives: Drug: Arhalofenate; Drug: Febuxostat; Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Measured: Day 29
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Measured: Day 29
Absolute and percent reduction in sUA from baseline on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Measured: Day 29
AUC(0-t) of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Measured: Days 14, 28, and 42
AUC(0-tau) of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Measured: Days 14, 28, and 42
Tmax of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Measured: Days 14, 28, and 42
Cmax of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Measured: Days 14, 28, and 42
Secondary outcomes (11)
Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Measured: Day 29
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Measured: Day 29
Absolute and percent reduction in sUA from baseline on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Measured: Day 29
Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 22 after treatment with arhalofenate 800 mg and febuxostat 40 mg, and with arhalofenate 600 mg and febuxostat 80 mg
Measured: Day 22
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 22 after treatment with arhalofenate 800 mg and febuxostat 40 mg, and with arhalofenate 600 mg and febuxostat 80 mg
Measured: Day 22
Absolute and percent reduction in sUA from baseline on Day 22 after treatment with arhalofenate 800 mg and febuxostat 40 mg, and with arhalofenate 600 mg and febuxostat 80 mg
Measured: Day 22
Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL after monotherapy treatment with arhalofenate 600 or 800 mg, or febuxostat 40 or 80 mg
Measured: Day 15 or Day 43
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline after monotherapy treatment with arhalofenate 600 or 800 mg, or febuxostat 40 or 80 mg
Measured: Day 15 or Day 43
Absolute and percent reduction in sUA from baseline on Day 15 after monotherapy treatment with arhalofenate 600 or 800 mg
Measured: Day 15
Absolute and percent reduction in sUA from baseline on Day 43 after monotherapy treatment with febuxostat 40 or 80 mg
Measured: Day 43
Kel and T1/2 of arhalofenate 800 mg and febuxostat 80 mg, if possible, when administered separately and in combination
Measured: Days 14, 28, and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra Steinberg, MD, PhD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252835
- Sponsor's protocol ID
- CB102-21426
- Status last verified
- Mar 2015
- First submitted
- 20 Sep 2014
- Last updated
- 18 Sep 2026
- Results posted
- No
Publications
Steinberg AS, Vince BD, Choi YJ, Martin RL, McWherter CA, Boudes PF. The Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout. J Rheumatol. 2017 Mar;44(3):374-379. doi: 10.3899/jrheum.161062. Epub 2016 Dec 15.
PubMed 27980008