NCT03150498已完成1 期
A Phase 1 Cross-over Study to Determine Food Effects on the Pharmacokinetics of Oral BTD-001 and Metabolites in Healthy Volunteers, Followed by an Optional Multiple Dose Study to Assess Pharmacokinetics of Oral BTD-001
Balance Therapeutics1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年5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
- 12
- 试验地点
- 1
- 主要终点
- Part 1 & Part 2 - Cmax of BTD-001 and major metabolites
研究概览
简要总结
This is a single-centre, open-label study in healthy male and non-pregnant, non-lactating females. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data.
Part 1 is a single dose, two period crossover to assess food affect of oral BTD-001.
Optional Part 2 is a non-randomised, single arm study multi dose design to evaluate PK profile of BTD-001
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and non-pregnant, non-lactating females aged 18-55 years old
- •BMI between18.0-35.0 kg/m2 unless investigator deems not clinically significant
- •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.
- •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 of >430 msec in males and >450 msec in females
- •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,hormone replacement therapy and hormonal contraception) or herbal remedies
- •Failure to satisfy the investigator of fitness to participate for any other reason
研究组 & 干预措施
BTD-001 (fasted)
Experimental
干预措施: BTD-001 (Drug)
BTD-001 (fed)
Experimental
干预措施: BTD-001 (Drug)
结局指标
主要结局
Part 1 & Part 2 - Cmax of BTD-001 and major metabolites
时间窗: [Maximum 30 days]
Maximum Observed Plasma Concentration
Part 1 & Part 2 - T1/2 of BTD-001 and major metabolites
时间窗: [Maximum 30 days]
elimination half-life
Part 1 & Part 2 - Tmax of BTD-001 and major metabolites
时间窗: [Maximum 30 days]
Time to Maximum Observed Plasma Concentration
Part 1 & Part 2 - AUC(0-last): of BTD-001 and major metabolites
时间窗: [Maximum 30 days]
Area Under the Curve for Observed Plasma Concentration
次要结局
- Vital Signs([Maximum 30 days])
- ECG([Maximum 30 days])
- Physical Examination([Maximum 30 days])
- Adverse Events([Maximum 30 days])
- Safety Lab Test([Maximum 30 days])
- Likert Scales([Maximum 30 days])
研究者
研究点 (1)
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