A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects
| Registry | NCT04303039 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | Atom Therapeutics Co., Ltd (Industry) |
| Conditions | Gout, Food-drug Interaction |
| Interventions | ABP-671 (Drug) |
| Dates | start 2020-05-22, primary completion 2020-06-09, completion 2020-06-19, first posted 2020-03-10, last updated 2020-06-23 |
| Locations | 1 site in United States |
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All trials for Gout All trials for Food-drug Interaction All trials of ABP-671
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Treatment A | Experimental | Drug: ABP-671 | Single 1.0 mg dose of ABP-671 in the fasted state. |
| Treatment B | Experimental | Drug: ABP-671 | Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast. |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Pharmaron CPC, Inc. | Baltimore, Maryland | United States |