Hypothyroidism Treatment in Aging and Thyroid Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- CL/F
研究概览
简要总结
This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine
详细描述
Setting The study was conducted on the clinical research unit of an academic medical center.
Participants Adults of any age being treated with levothyroxine for hypothyroidism were studied.
Interventions A single dose of 13C- LT4 was administered to hypothyroid subjects taking levothyroxine replacement.
Main Outcomes and Measures Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the remainder over the 312-hour period post-dosing. 13C- LT4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. Pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using Phoenix 6.4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >21 years at the time of consent
- •euthyroidism while undergoing treatment with LT4
- •no other serious illness
- •ability to give written informed consent.
排除标准
- •baseline hematocrit lower than 28.0%
- •TSH greater than 4.5 mIU/L
- •kidney dysfunction
- •concomitant use of drugs that affect thyroidal axis interactions
研究组 & 干预措施
Stable isotope arm
Measurement of blood levels of labelled levothyroxine after administration of single oral dose of stable isotope levothyroxine
干预措施: Administration of stable Isotope labeled levothyroxine (Drug)
结局指标
主要结局
CL/F
时间窗: 120 hours
oral clearance rate (defined as the ratio of dose administered to AUC0-∞)
V/F
时间窗: 120 hours
apparent volume of distribution (estimated by CL/F/ λ)
t-half
时间窗: 120 hours
the half-life of the terminal disposition phase (t-half) estimated by ln(2)/λ .
次要结局
- V/F analysed by age groups(120 hours)
- t-half by age groups(120 hours)
- CL/F analysed by age groups(120 hours)