NCT04303039已完成1 期
A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Plasma ABP-671 Concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- •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.
- •Subjects who previously received ABP-
- •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.
研究组 & 干预措施
Treatment A
Experimental
Single 1.0 mg dose of ABP-671 in the fasted state.
干预措施: ABP-671 (Drug)
Treatment B
Experimental
Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast.
干预措施: ABP-671 (Drug)
结局指标
主要结局
Plasma ABP-671 Concentration
时间窗: 72 hours
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
次要结局
- Serum Uric Acid Concentration(72 hours)
- Urine Uric Acid Concentration(72 hours)
- Serum Creatinine Concentration(72 hours)
- Urine Creatinine Concentration(72 hours)
研究者
研究点 (1)
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