Status:
COMPLETED
Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects
Lead Sponsor:
Atom Therapeutics Co., Ltd
Conditions:
Gout
Food-drug Interaction
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04303039
Start Date
May 22 2020
End Date
June 19 2020
Last Update
June 23 2020
Active Locations (1)
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1
Pharmaron CPC, Inc.
Baltimore, Maryland, United States, 21201