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Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout

NCT02252835 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-04-17

No results posted yet for this study

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.

Conditions

  • Gout
  • Hyperuricemia

Interventions

DRUG

Arhalofenate

800 mg once daily orally for four weeks

DRUG

Febuxostat

40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks

DRUG

Arhalofenate

600 mg once daily orally for four weeks

DRUG

Febuxostat

80 mg once daily orally for 1 week then down-titrated to 40 mg once daily orally for another three weeks

DRUG

Colchicine

0.6 mg daily

Sponsors & Collaborators

Principal Investigators

  • Alexandra Steinberg, MD, PhD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252835 on ClinicalTrials.gov