An Open Label Trial to Assess the Effects of Food on the Pharmacokinetic Parameters of Obeticholic Acid (OCA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax) - fed and fasted
研究概览
简要总结
This is an open label, randomized, balanced, single center, single dose, trial to assess the pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence, crossover manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are required to meet the following criteria in order to be included in the trial.
- •Male or female subjects from 18 to 55 years
- •Contraception: Female subjects must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use more than 1 effective (≤ 1% failure rate) method of contraception during the trial and until at least 30 days after the last dose of OCA. Effective methods of contraception are considered to be:
- •Double barrier method, ie, (a) condom (male or female) with spermicide or (b) diaphragm with spermicide
- •Intrauterine device (IUD)
- •Good general health as determined by medical history, and by results of physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests obtained within 14 days prior to Day 0
- •Body mass index (BMI) of 18 to 28; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- •Willing to abstain from alcohol, caffeine, and xanthine-containing food and beverages for 72 hours prior to each period check in and during participation of the inpatient periods of the trial
- •Willing and able to give written informed consent
排除标准
- •Subjects meeting the following criteria will be excluded from the trial.
- •Prior participation in a clinical trial of OCA (INT-747; 6-ECDCA)
- •History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease
- •History of gastrointestinal surgeries or gall bladder removal (cholecystectomy)
- •History or presence of a clinically significant cardiovascular, hepatic, diabetic, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, psychiatric, or neoplastic disorder(s)
- •History of known or suspected clinically significant hypersensitivity to any drug, aside from penicillin
- •Ingestion of a prescription medication within 14 days prior to Day 0 or ingestion of an over the counter medication within 7 days prior to Day 0
- •Participation in radiologic examinations involving parenteral administration of iodinated contrast materials within 2 weeks prior to screening, or subsequently, through the end of trial participation
- •History or presence of alcohol abuse (defined as consumption of more than 210 mL of alcohol per week; or the equivalent of fourteen 4 ounces (oz) glasses of wine, or fourteen 12 oz cans/bottles of beer or wine coolers per week)
- •History or presence of substance abuse within the past 2 years or positive drug screen tests
- •Smoker or user of tobacco or nicotine products
- •Any screening laboratory test for which the results are not within the normal reference range and considered clinically significant
- •Participation in another investigational drug trial within 30 days prior to Day 0
- •History of noncompliance to medical regimens, or subjects who are considered to be potentially unreliable
- •Blood or plasma donation within 30 days prior to Day 0
- •Mental instability or incompetence
- •Presence of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at screening
研究组 & 干预措施
OCA 10 mg while fasted
OCA 10 mg orally in the fasting state
干预措施: OCA 10 mg (Drug)
OCA 10 mg while Fed
OCA 10 mg orally in the fed state
干预措施: OCA 10 mg (Drug)
OCA 25 mg while fasted
OCA 25 mg orally in the fasting state
干预措施: OCA 25 mg (Drug)
OCA 25 mg while Fed
OCA 25 mg orally in the fed state
干预措施: OCA 25 mg (Drug)
结局指标
主要结局
Maximum concentration (Cmax) - fed and fasted
时间窗: Day 1 and Day 14: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 14 hours
maximum concentration (observed)
Time to maximum concentration (Tmax)
时间窗: 24 hours
Time to maximum concentration
Area under the concentration versus time (AUCt)
时间窗: 216 hours
Area under the concentration versus time curve from time 0 to the last sampling time with measurable analyte concentration.
Area under the concentration versus time curve from 0 to 24 hours (AUC 0-24)
时间窗: 24 hours
Area under the concentration versus time curve from 0 to 24 hours with measurable analyte concentration
次要结局
未报告次要终点