NCT01367262已完成1 期
Disposition of [14C]-LY2886721 Following Oral Administration in Healthy Human 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 Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
研究概览
简要总结
This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males as determined by medical history and physical examination
- •Males will be sterile (including vasectomy) or if the participant is not sterile and is sexually active, he will agree to use from check-in until 3 months after exit/discharge, 1 of the following approved methods of contraception: a male condom with spermicide, a sterile sexual partner, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, intravaginal, or injectable contraceptives
- •Have a body mass index of 19 to 30 kilograms per square meter (kg/m^2)
- •Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- •Have venous access sufficient to allow for blood sampling
- •Have normal blood pressure and heart rate (sitting)
- •Experience a minimum of at least 1 bowel movement per day
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site
排除标准
- •Are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •Have known allergies to LY2886721, related compounds, or any components of the formulation
- •Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2886721
- •Have a Bazett's corrected QT (QTcB) interval value of >450 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) increases the risks associated with participating in the study
- •Have an abnormal blood pressure
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •Intend to use prescription medication, over-the-counter medication, or herbal preparations containing St. John's Wort, kava, garlic, ginger, ginko biloba, or guarana within 14 days prior to admission
- •Eating of grapefruit or grapefruit-containing foods, or drinking grapefruit-containing juices within 7 days prior to dosing or any time during the study
- •Have used any tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to dosing
- •Have donated blood of more than 500 milliliters (mL) within the last month
- •Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65), or are unwilling to stop alcohol consumption from 48 hours prior to check-in until end of study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
- •Show evidence of significant active neuropsychiatric disease, in particular evidence of significant medical or psychiatric illness within the past 12 months. Have any other condition that would preclude participation in the study
- •Have a history or presence of epilepsy, a history of seizures, any known brain abnormalities, and a history of significant brain injury
- •Have participated in a [^14C] study within the last 6 months prior to check-in for this study. The total exposure from this study and the previous study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1), less than 5,000 millirems (mrem)/year whole body annual exposure
- •Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
- •Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)
- •Have a history of, or current, significant ophthalmological disease
- •Have evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance of <80 milliliters per minute (mL/min) as calculated by Cockcroft-Gault equation: Men: (140-age)*weight in kilograms (kg)/72*[serum creatinine in milligrams per deciliter (mg/dL)]
研究组 & 干预措施
Radiolabeled LY2886721
Experimental
Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721
干预措施: LY2886721 (Drug)
结局指标
主要结局
Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
时间窗: Predose up to 7 days (168 hours) postdose
Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=\[(Total Ae)/(Total radioactive dose administered)\]\*100.
次要结局
- Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)](Predose up to 4 days (96 hours) postdose)
- PK of Radioactivity: AUC(0 to Inf)(Predose up to 4 days (96 hours) postdose)
- Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)(Predose up to 4 days (96 hours) postdose)
- PK of Radioactivity: Cmax(Predose up to 4 days (96 hours) postdose)
- Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma(1 to 8 hours postdose)
- Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine(0 to 72 hours postdose)
- Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces(0 to 144 hours postdose)
研究者
研究点 (1)
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