Pharmacokinetics, Metabolism and Elimination of Tritiated [3H] BMS747158 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To assess safety and the extent and route of [3H] radioactivity eliminated (mass balance) in urine and feces following a single intravenous (IV) dose of approximately 100 (±20) µCi of [3H] BMS747158 in healthy male subjects.
研究概览
简要总结
The purpose of this clinical study is to assess the safety, extent and route of [3H] BMS747158 radioactivity eliminated (mass balance) in urine and feces of healthy male subjects. The safety of [3H] BMS747158 administration will also be assessed, as well as pharmacokinetics of [3H] BMS747158 and metabolite identification.
详细描述
This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100 (±20) μCi of [3H] BMS747158. Subjects will undergo blood, urine, and fecal collections to evaluate [3H] activity for a minimum of 7 days post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).This Phase I, nonrandomized, open-label study will enroll up to seven healthy male subjects who meet all of the inclusion and none of the exclusion criteria. Subjects will receive 100 (±20) μCi of [3H] BMS747158. Subjects will undergo blood, urine, and fecal collections to evaluate [3H] activity for a minimum of 7 days post-dose. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examinations, clinical laboratory tests, and electrocardiograms (ECGs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provide written signed informed consent prior to any study procedures
- •Be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory tests
- •Have a Body Mass Index (BMI) of 18 to 30 kg/m2
- •Be male, age 18 to 45 years
- •Be sterile or agree to use from admission until discharge one 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 (IUD) with spermicide *a female condom with spermicide contraceptive sponge with spermicide
- •an intravaginal system [e.g., NuvaRing®]
- •a diaphragm with spermicide
- •a cervical cap with spermicide, or
- •oral, implantable, transdermal, or injectable contraceptives
- •Must be able to communicate effectively with study personnel
排除标准
- •Any significant active or chronic medical illness or acute significant trauma
- •History of any condition that may disrupt and/or increase permeability of the blood-brain barrier or diabetes
- •History of any neurological disease.
- •History of concussion or meningitis within the past 6 months
- •History of sleep disorders, including snoring with sleep apnea and narcolepsy
- •History of anxiety disorder
- •Current or recent GI disease
- •Major surgery within 4 weeks
- •GI surgery that could impact upon the re-absorption of study drug
- •History of chronic constipation
- •History of asthma as deemed clinically significant by the Investigator or designee
- •History of recent (within 2 weeks of enrollment) infection (e.g., upper respiratory tract infection, urinary tract infection)
- •Known and confirmed drug allergies or hypersensitivities
- •Donation of blood and/or plasma to a blood bank or in a clinical study (except as required for screening) within four weeks of enrollment
- •Blood transfusion within four weeks of enrollment
- •Inability to tolerate intravenous medication or unlikely to obtain and/or tolerate venous access
- •Past (6 months) or present history of drug or alcohol abuse
- •Screening or pre-dose ECG interval abnormalities or organ dysfunction.
- •Positive urine screen for drugs of abuse either at screening or before dosing
- •Positive blood screen for hepatitis B surface antigen, hepatitis C antibody, or HIV
- •Exposure to any investigational drug, device, or placebo within four weeks of enrollment
- •Use of any prescription drugs within 4 weeks of enrollment
- •Use of any other drugs, including over-the-counter medications (e.g., acid-controllers) and herbal preparations within two weeks of enrollment
- •Smoking within 1 month of enrollment
- •Alcohol or caffeine consumption within 72 hours of study drug administration
- •Participation in a radio-labeled study within 12 months of enrollment
- •Intake of radio-labeled drug substance or exposure to significant radiation
- •Participation in any prior study with BMS747158
研究组 & 干预措施
Single Arm
Single arm PK study
干预措施: [3H] BMS747158 (Drug)
结局指标
主要结局
To assess safety and the extent and route of [3H] radioactivity eliminated (mass balance) in urine and feces following a single intravenous (IV) dose of approximately 100 (±20) µCi of [3H] BMS747158 in healthy male subjects.
时间窗: August 2009
次要结局
- To assess the pharmacokinetics (PK) of [3H] radioactivity and of [3H] BMS747158 in blood. To identify the major metabolites of [3H] BMS747158 present in blood, urine, and feces(August 2009)