An Open Label, Two Period, Sequential, Single Dose and Multiple Dose Pharmacokinetic Study With 0.6mg Colchicine Tablets in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum Serum Concentration (Cmax)
研究概览
简要总结
This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.
详细描述
This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers. After a fast of at least 10 hours, fourteen healthy non-smoking, non-obese, non-pregnant volunteers will receive a single oral dose of colchicine 0.6 mg. Fasting will continue for 4 hours after the dose, at which time a standard meal will be served. Blood will be drawn from all participants at times sufficient to adequately define the single dose pharmacokinetics of colchicine and its 3 major metabolites, 2, 3 and 10 demethylcolchicine. Following a 14 day washout period, all participants will begin a 10 day regimen of colchicine 0.6 mg orally every 12 hours. On the morning of day 25, after a fast of at least 10 hours, all participants will receive their final dose of colchicine 0.6 mg. Again blood will be drawn at times sufficient to determine the pharmacokinetics of colchicine and its 3 major metabolites after chronic dosing. The pharmacokinetic parameters for each dosing situation will be derived and compared for relevant differences. Though not a specific goal of this study, all participants will be monitored for adverse events by observation and query during periods of confinement on days 1, 15 and 25, as well as by complete blood count (CBC) with differential and clinical chemistry, sitting and standing blood pressures, and heart rate and 12-lead electrocardiogram (EKG) before and after dosing, on days 1 and 25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completion of the screening process within 28 days prior to Period I dosing
- •Healthy non-smoking, non-obese adult men and women volunteers between the ages of 18 to 45 years of age, weighing at least 110 with a body mass index of 18-30kg/m2
- •Women must be postmenopausal, surgically sterile, commit to abstinence from heterosexual sexual contact or use two methods of contraception.
排除标准
- •Pregnant or lactating
- •Use of any investigational drug within 28 days prior to Period I dosing.
- •Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s)
- •Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- •Clinical laboratory test values outside the accepted reference range and when confirmed on re-examination.
- •Any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators)
- •Use of any systemic prescription medication in the 14 days prior to Period I dosing
- •History of any allergy(s) including allergy to colchicine or related drugs.
- •History of drug or alcohol addiction or abuse within the past year or a positive drug abuse screen
- •Currently or recent (within 6 months) use of tobacco products prior to dose administration
- •Donation of greater than 150 mL of blood within 28 days or plasma within 14 days prior to period I dosing
研究组 & 干预措施
1
0.6mg colchicine tablet
干预措施: colchicine tablets (Drug)
2
colchicine 0.6mg q12 hours for 10 days
干预措施: colchicine tablets (Drug)
结局指标
主要结局
Maximum Serum Concentration (Cmax)
时间窗: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing
maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions
Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.
时间窗: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)
时间窗: 0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
次要结局
未报告次要终点