NCT03107013已完成1 期
An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BTD-001 in Healthy Male Subjects
Balance Therapeutics1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001
研究概览
简要总结
This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males aged 30-65 years old
- •BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant
- •Regular daily bowel movements
- •Provide written consent
- •Agrees to protocol specified contraception
排除标准
- •Received any investigational treatment within last 3 months
- •Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •Subjects who have previously been enrolled in this study
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males >21 units per week
- •Current smokers and those who have smoked, including nicotine replacement or e-cigarates within the last 12 months.
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- •Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- •Clinically significant abnormal lab results
- •Positive drugs of abuse test result
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •Evidence of renal impairment at screening
- •History of or current seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
- •Clinically significant medical/psychiatric history findings, or physical/neurological examination findings or significant history of or current suicidal ideation or behaviour
- •History of or current significant pulmonary, cardiac, renal, hepatic, chronic respiratory, gastrointestinal, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carcinomas or local cervical squamous cell cancer resolved after resection) or hypothyroidism
- •Subjects with QT interval corrected for heart rate according to Fridericia's formula >450 msec
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than up to 4 g per day paracetamol) or herbal remedies
- •Failure to satisfy the investigator of fitness to participate for any other reason
研究组 & 干预措施
[14C]-BTD-001
Experimental
干预措施: [14C]-BTD-001 (Drug)
结局指标
主要结局
Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001
时间窗: Maximum 12 days
The percentage of radioactive dose of \[14C\] radiolabelled BTD-001 recovered in urine, faeces, and plasma
Metabolite Profiling
时间窗: Maximum 12 days
To provide plasma, urine and faecal samples for metabolite profiling and structural identification
次要结局
- Determination of routes and rates of elimination of [14C]-BTD-001(Maximum 12 days)
- Determination of the chemical structure of the "major" metabolites of [14C]-BTD-001(Maximum 12 days)
- Evaluation of whole blood:plasma concentration ratios for total radioactivity(Maximum 12 days)
- physical examination(Maximum 12 days)
- safety laboratory tests(Maximum 12 days)
- Vital signs(Maximum 12 days)
- ECGs(Maximum 12 days)
- AEs(Maximum 12 days)
研究者
研究点 (1)
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