Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout

2014-08-27 03:13:27 | BioPortfolio


To evaluate safety and efficacy of BCX4208 alone and in combination with allopurinol in subjects with gout.


This study is a Phase 2, randomized, double-blind, multi-center, placebo-controlled study to evaluate efficacy and safety of BCX4208 alone and in combination with allopurinol in approximately 80 subjects with gout. The study is a factorial design, evaluating doses of BCX4208 previously found to be safe and well-tolerated in healthy subjects and subjects with psoriasis and gout. Doses of allopurinol are according to package insert recommendations.

Approximately 80 subjects will be randomized equally to one of 16 treatment groups.

The study will consist of 3 periods: the Screening Period, the Treatment Period, and the Follow-Up Period. The Screening period will be conducted within Day -30 to Day -1, as long as all inclusion and exclusion criteria are satisfied (see Section 8). For subjects receiving urate-lowering therapy; these subjects must discontinue the urate-lowering therapy by Day -14 to assure a washout period of at least 14 days before entering the Treatment Period. Some Screening procedures such as a recording of medical history and clinical laboratory tests performed at Screening only may be performed at any time during the Screening Period (Day -30 to Day -1). Other Screening procedures must be performed within the 7 days prior to the first dose of study drug (i.e., from Day -7 to Day -1); these include: physical examination, height, weight, clinical chemistry (including baseline and qualifying sUA), hematology, and urinalysis evaluations, CD4+, CD8+, CD20+, and CD56+ lymphocyte counts, a serum pregnancy test in females of child-bearing potential, 12-lead ECG, and vital signs assessments. An otherwise qualified subject may have up to 2 repeated determinations of sUA and/or lymphocyte subsets assayed to meet the entry criteria for this study, as long as the qualifying sUA and lymphocyte subsets assays occur 7 or fewer days prior to the first dose of study drug. These assessments will constitute the Baseline assessments for the purpose of comparisons with these same assessments post-dose.

Gout flare prophylaxis with colchicine or naproxen is required to be started prior to the first dose of study drug. Colchicine 0.6 mg once a day will begin at least 7 days prior to Day 1, or naproxen 250 mg twice daily will be started at least 48 hours prior to Day 1. For subjects who discontinue urate-lowering therapy, the required gout flare prophylaxis will begin at or before the cessation of the urate-lowering therapy.

A recording of concomitant medications and AEs will take place from the time of the signing of the Informed Consent Form (ICF) and throughout the duration of the study.

The Treatment Period begins on Day 1. Subjects are to arrive at the study clinic on Day 1 after an overnight fast. After a final review of eligibility criteria, pre-dose vital signs assessments, and BCX4208, allopurinol, and oxypurinol PK blood draw have been performed, subjects will be randomized and administered the first dose of study drug. Subjects will remain in the study clinic for Hour 2, Hour 4, and Hour 8 PK sampling and will return to the study clinic for efficacy and safety evaluations prior to dosing on Days 2, 8, and 15.

Subjects will take study drug daily from Day 1 to Day 21, so that the Day 22 evaluation will occur approximately 24 hours after the last dose of study drug. After the Day 22 evaluation, subjects will enter the Follow-Up Period and will return to the study clinic on Day 29 for safety evaluation. Subjects may resume their prior urate-lowering therapy after the assessments on Day 29.

Subjects who on Day 29 have unresolved treatment-emergent AEs will be followed beyond Day 29 until either resolution of the AE or until clinically stable. This subset of subjects will conclude their study participation at the Day 50 Telephone Safety Follow-Up Contact.

Efficacy will be assessed during the study by means of sUA concentrations. Safety will be assessed during the study by means of physical examination, weight, clinical chemistry, hematology, and urinalysis parameters, absolute CD4+, CD8+, CD20+, and CD56+ lymphocyte counts, 12-lead ECG, vital signs assessments, and AE assessments.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment




Placebo, Allopurinol, Allopurinol, Allopurinol, BCX4208, Allopurinol, Allopurinol, Allopurinol, BCX4208, Allopurinol, Allopurinol, Allopurinol, BCX4208, Allopurinol, Allopurinol, Allopurinol, BCX4208


United States




BioCryst Pharmaceuticals

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:27-0400

Clinical Trials [79 Associated Clinical Trials listed on BioPortfolio]

Allopurinol Combination Study

To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alo...

Allopurinol and Endothelial Function in Diabetic CAD Patients

This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subject...

Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence.

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic evaluat...

Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia

The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia.

Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients

Main Study Objectives: The study is conducted to - evaluate the minimal allopurinol and azathioprine doses that, in combination, produce therapeutic 6-TGN levels -...

PubMed Articles [877 Associated PubMed Articles listed on BioPortfolio]

The Teratogenicity of Allopurinol: A comprehensive review of animal and human studies.

Allopurinol is widely used in the management of multiple disorders including gout, kidney stones and inflammatory bowel disease. Despite of long-term experience, its safety in pregnancy has been debat...

l-Arginine and allopurinol supplementation attenuates inflammatory mediators in human osteoblasts-osteoarthritis cells.

This study investigated the synergistic effects of l-arginine and allopurinol on antioxidant and inflammatory mediators in human osteoblasts-osteoarthritis (HOb-OA) cells. The cells were treated with ...

Update on therapy and prevention of canine leishmaniasis.

Canine leishmaniasis is an emerging infection with increasing importance because the main vector also exists in Germany and autochthonous infections have been described. In this article we present the...

Efficacy of the HLA-B58:01 screening test in preventing allopurinol-induced severe cutaneous adverse reactions in patients with chronic renal insufficiency- a prospective study.

Thus far, human leukocyte antigen (HLA)-B58:01 has been recognized as the most important risk factor for allopurinol induced severe cutaneous adverse reactions (SCARs).

Behavioral and neurodevelopmental outcome of children after maternal allopurinol administration during suspected fetal hypoxia: 5-year follow up of the ALLO-trial.

To evaluate the long-term neurodevelopmental and behavioral outcome of antenatal allopurinol treatment during suspected fetal hypoxia.

Medical and Biotech [MESH] Definitions

A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

More From BioPortfolio on "Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout"

Quick Search


Relevant Topics

According to the National Arthritis Data Workgroup, an estimated 6 million people in the United States report having experienced gout at some point in their lives. In fact, gout is the most common form of inflammatory arthritis in men over the age of 40....

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial