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

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

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.

Study Overview

• Status: Completed
• Conditions: Gout; Food-drug Interaction
• Intervention / Treatment: Drug: ABP-671

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron CPC, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): June 19, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ABP-671-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No