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

Atom Bioscience

Status and phase

Completed

Phase 1

Conditions

Food-drug Interaction

Gout

Treatments

Drug: ABP-671

Study type

Interventional

Funder types

Industry

Identifiers

NCT04303039

ABP-671-103

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

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.