a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of abp-671

Conditions: Hyperuricemia; Gout

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of abp-671 administered orally in subjects with hyperuricemia.


Eligibility criteria:
inclusion criteria: * subjects must be medically documented as healthy and acceptable at screening. * subjects must have serum uric acid level at screening ≥ 7.0 mg/dl for men, ≥ 6.0 mg/dl for women. * subjects must have a body mass index (bmi) between 18.0 and 34.0 kg/m2 (inclusive). * subjects must have a body weight of 50 kg or higher. * the subject agrees to abstain from alcohol consumption for 48 hours prior to dosing, for the duration of the in-house study period, and for 48 hours prior to each in-clinic follow up visit. * the subject is a nonsmoker. * women must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal for ≥ 12 months. * men must be surgically sterile, abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the participant must be using a condom with spermicide from screening and for a period of 30 days after the last dose of study drug. the investigator will assess the adequacy of methods of contraception on a case-by-case basis. * subjects must have a complete blood count (cbc) and platelet count within the normal range or considered not clinically significant by the principal investigator. * other than elevated serum uric acid, subjects must have normal blood chemistry or results considered not clinically significant by the investigator. * subjects must have a normal urinalysis or results considered not clinically significant by the investigator including a normal protein/creatinine ratio per local lab reference ranges (≤ 200 mg/g) and a urine creatinine result that does not exceed 300 mg/dl. any out of range values may be repeated per investigator discretion. * subjects must have a normal ecg or results considered not clinically significant by the principal investigator. * subjects must be able to comply with the study and follow-up procedures. * subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study. exclusion criteria: * subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders. * subjects who are positive for human immunodeficiency virus (hiv), hepatitis b surface antigen, and/or hepatitis c virus. * subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 3 weeks before day 1 of study medication dosing. * subjects who are positive for urine drug and alcohol screening tests. * subjects who have undergone major surgery within 3 months prior to day 1. * women who are pregnant or breastfeeding. * subjects who received any investigational test article within 5 half-lives or 30 days, whichever is longer, prior to day 1 study medication dosing. * recent blood donation for more than 500 ml within 2 months of screening. * abnormal ecg including qtc \> 470 (f) and \> 450 (m). * subjects who consumed seville oranges- or grapefruit-containing foods or beverages within 7 days before day 1 and during the entire study duration. * subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study. * prior exposure to abp-671.

Keywords: gout hyperuricemia