Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects

Conditions
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Gout, Food-drug Interaction

Intervention / Treatment
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* Drug: ABP-671


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single 1.0 mg dose of ABP-671 in the fasted state. | Drug: ABP-671<br>* ABP-671 Tablet 1.0 mg<br>|
| Experimental: Treatment B<br>Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast. | Drug: ABP-671<br>* ABP-671 Tablet 1.0 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma ABP-671 Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Uric Acid Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours | 
| Serum Creatinine Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours | 
| Urine Uric Acid Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours | 
| Urine Creatinine Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours |