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

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.1 site in 1 country12 target enrollmentMay 22, 2020

ConditionsGout Food-drug Interaction

InterventionsABP-671

DrugsABP-671

Overview

Phase: Phase 1
Intervention: ABP-671
Conditions: Gout
Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Enrollment: 12
Locations: 1
Primary Endpoint: Plasma ABP-671 Concentration
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 22, 2020

End Date

June 19, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 to 60 years, inclusive
•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

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 -
•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
•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.