NCT00599612已完成1 期
An Open Label Study to Determine the Safety, Tolerability, Excretion Balance and Pharmacokinetics of [14C]GW856553, Administered as a Single Dose of an Oral Solution to Healthy Adult Male 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
- 6
- 试验地点
- 1
- 主要终点
- Percentage of the total radioactive dose administered over time
研究概览
简要总结
This will be an open label study conducted at one site. Six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single 10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine and fecal samples will be collected until 216 hour after dosing but subjects may be discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted in a 24 hour period. Blood and plasma will be collected at various sample times after dosing to measure parent drug and total drug-related material. Samples of urine, faeces and plasma will be transferred into a separate study to characterize and quantify metabolites in these matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram (ECG) and clinical laboratory tests.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male aged between 30 and 60 years inclusive, at the time of screening.
- •Body weight >/ 50 kilogram (kg).
- •A body mass index (BMI) within the range of 18.5 to 29.9 kg/ meter square (m^2) inclusive.
- •Signed and dated written informed consent prior to admission to the study.
- •The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
排除标准
- •Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12-lead).
- •Significant cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial.
- •QT interval corrected by Bazett's Formula (QTcB) > 450 milliseconds (msecs)
- •A definite or suspected personal or family history of adverse reactions or hypersensitivity to the trial drug or to drugs with a similar chemical structure.
- •History of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units). One unit is equivalent to a half-pint [284 milliliter (mL)] of beer/lager; 25mL measure of spirits or 125mL of wine).
- •Subjects with a history or presence of gastro-intestinal or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Subjects who have consumed grapefruit or grapefruit juice within seven days of the first study day.
- •Subjects who have had exposure to more than three new chemical entities within 12 months prior to the first dosing period.
- •Subjects who have participated in a trial with a different new chemical entity within 90 days prior to the start of this study.
- •If participation in the study will result in the volunteer having donated more than 400mL of blood in the previous 56 days.
- •Subjects who have received a total body radiation dose of greater than 5.0 mSv (upper limit of WHO category II) or exposure to significant radiation (e.g. serial X-ray or CT scans, barium meal etc) in the 12 months prior to this study.
- •History of elevated blood pressure or blood pressure persistently >140/90 mmHg at screening.
- •An unwillingness to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, sub dermal implants or a tubal ligation if the women could become pregnant from the time of the first dose of the study medication until completion of the follow-up procedures.
- •Lack of suitability for participation in this study, for any reason, in the opinion of the investigator.
- •Any condition that could interfere with the accurate assessment and recovery of 14C.
- •Prescribed or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) prior to the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
- •Liver function tests (ALT, AST, ALP, Gamma GT and bilirubin) > upper limit of normal (ULN) at screening
- •Positive urine drug screen
- •Positive HIV, Hepatitis B or C result at screening.
- •History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive urine cotinine screen (urine cotinine > 250ng/ml).
研究组 & 干预措施
Healthy male volunteers
Experimental
Six healthy male volunteers aged between 30-60 years old will be recruited for this study,
干预措施: GW856553 (Drug)
结局指标
主要结局
Percentage of the total radioactive dose administered over time
时间窗: Up to 10 days
The urinary and fecal cumulative excretion will be analyzed.
次要结局
- Tmax of GSK198602(Pre-dose and 1, 4, 12 hours post-dose)
- T1/2 of GW856553(Pre-dose and 1, 4, 12 hours post-dose)
- Cmax of GSK198602(Pre-dose and 1, 4, 12 hours post-dose)
- AUC(0-t) of GW856553(Pre-dose and 1, 4, 12 hours post-dose)
- Area under the concentration time curve (AUC) from time zero to infinity (AUC[0-inf]) of total drug(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)
- Maximum plasma concentration(Cmax) of total drug(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)
- Terminal plasma half-life (t1/2) of total drug(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)
- AUC(0-inf) of GW856553(Pre-dose and 1, 4, 12 hours post-dose)
- Cmax of GW856553(Pre-dose and 1, 4, 12 hours post-dose)
- AUC from zero to the time of the last measurable concentration (AUC[0-t]) of total drug(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)
- AUC(0-inf) of GSK198602(Pre-dose and 1, 4, 12 hours post-dose)
- Tmax of GW856553(Pre-dose and 1, 4, 12 hours post-dose)
- Number of subjects with abnormal ECG findings(Up to 15 days)
- First time of occurrence of maximum observed concentration (Tmax) of total drug(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose)
- AUC(0-t) of GSK198602(Pre-dose and 1, 4, 12 hours post-dose)
- Number of subjects with abnormal blood pressure values(Up to 15 days)
- Number of subjects with Adverse events (AEs) and serious adverse events (SAEs)(Up to 15 days)
- Number of subjects with abnormal clinical hematology parameters(Up to 15 days)
- T1/2 of GSK198602(Pre-dose and 1, 4, 12 hours post-dose)
- Number of subjects with abnormal heart rate values(Up to 15 days)
- Number of subjects with abnormal clinical chemistry parameters(Up to 15 days)
- Number of subjects with abnormal urine analysis parameters(Up to 15 days)
- Number of subjects with abnormal liver function tests(Up to 15 days)
研究者
研究点 (1)
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