study to investigate the effects of food on relative bioavailability of abp-671 tablets in healthy subjects

Conditions: Gout; Food-drug Interaction

Summary: this is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (ab or ba). treatments a and b will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 ml of water. each period will be separated by a washout interval of 4 days.


Eligibility criteria:
inclusion criteria: * male or female aged 18 to 60 years, inclusive * healthy * subjects must have the serum uric acid level at screening ≥ 3.7 mg/dl to ≤ 7.0 mg/dl for males, and ≥ 2.3 mg/dl to ≤ 6.0 mg/dl for females. * subjects must have a body mass index (bmi) between 18 and 35 kg/m2 at screening (inclusive). * subjects must have a body weight of 50 kg or higher. * females must be non-pregnant and non-lactating * males must be surgically sterile, abstinent, or if engaged in sexual relations with a female partner of child-bearing potential, be using a condom with spermicide * subjects must have a cbc and platelet count within normal range * subjects must have normal blood chemistry * subjects must have a normal urinalysis * subjects meeting inclusion and exclusion criteria must have a renal ultrasound determined to be normal or non-clinically significant * subjects must have a normal estimated glomerular filtration rate * subjects must have a normal ecg * 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 provided signed informed consent to participate in the study exclusion criteria: * subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders. * subjects with prior history of bariatric surgery, intestinal resection, malabsorption, or celiac disease with an exception of subjects with appendectomy. * subjects who have any history or suspicion of kidney stones or evidence of renal stones or opacification with renal ultrasound prior to dosing on day -1. * subjects who have any history of gout. * 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 14 days screening period before day 1 of study medication dosing. females who have received hormone replacement therapy (hrt) within 14 days prior to dosing. * subjects who are positive for urine drug 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. * subjects who previously received abp-671. * recent blood donation for more than 500 ml within 2 months of screening. * 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.