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CompletedNCT04303039Updated Jun 23, 2020

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

A Phase 1 interventional study of ABP-671 in Gout and Food-drug Interaction, sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.

Sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2020, 6 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gout
  • Food-drug Interaction
03

In context

Lead sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Treatment A

    Single 1.0 mg dose of ABP-671 in the fasted state.

    Drug: ABP-671

  • Experimental
    Treatment B

    Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast.

    Drug: ABP-671

Interventions

  • DrugABP-671

    ABP-671 Tablet 1.0 mg

06

What researchers measure

Primary outcomes

  1. Plasma ABP-671 Concentration

    At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

    Time frame: 72 hours

Secondary outcomes

  1. Serum Uric Acid Concentration

    At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

    Time frame: 72 hours

  2. Serum Creatinine Concentration

    At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

    Time frame: 72 hours

  3. Urine Uric Acid Concentration

    At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

    Time frame: 72 hours

  4. Urine Creatinine Concentration

    At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

    Time frame: 72 hours

07

Study locations

1 site
  • Pharmaron CPC, Inc.
    Baltimore, Maryland 21201, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04303039
Lead sponsor
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Mar 10, 2020
Start date
May 22, 2020
Primary completion
Jun 9, 2020
Completion
Jun 19, 2020
Last update
Jun 23, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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