Clinical trial NCT04303039: Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects
Official title: A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Food-drug Interaction
Lead sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plasma ABP-671 Concentration
timeFrame: 72 hours
Secondary outcomes:
measure: Serum Uric Acid Concentration
timeFrame: 72 hours
measure: Serum Creatinine Concentration
timeFrame: 72 hours
measure: Urine Uric Acid Concentration
timeFrame: 72 hours
measure: Urine Creatinine Concentration
timeFrame: 72 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC, Inc.
state: Maryland
Study officials:
References: