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

Completed · Phase 1

Conditions studied: Gout, Food-drug Interaction

In brief

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.

Key facts

Study ID

NCT04303039

Run by

Atom Therapeutics Co., Ltd

People needed

12

Starts

2020-05-22

Expected to finish

2020-06-19

Last updated by the study team

2020-06-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pharmaron CPC, Inc. — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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