Investigation of Safety/Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Doses of BYK324677 in Healthy Volunteers. A Monocentre, Placebo-controlled, Cross-over, Double-blind, Randomised Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
研究概览
简要总结
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Given written informed consent
- •Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results
- •Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg
排除标准
- •History or current evidence of specified diseases
- •History of malignancy in the past 5 years
- •Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months
- •ECG abnormalities of clinical relevance
- •Suspected hypersensitivity to the trial medication
- •Positive virology tests indicating acute or chronic infections
- •Clinically relevant laboratory parameters outside a specified range
- •Use of specified medications within certain time frames or use of certain co-medications
- •Abuse of alcohol or drugs
- •Dietary habits that would prevent from taking standardised meals
- •Female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial
- •Donation of blood
- •Smoking within the last 3 months
研究组 & 干预措施
BYK324677
- Dose group I: total daily dose 2 mg (1 mg BID or 2 mg SID)
- Dose group II: total daily dose 4 mg (2 mg BID or 4 mg SID)
- Dose group III: total daily dose 6 mg (3 mg BID or 6 mg SID)
In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned.
Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1.
Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner.
干预措施: BYK324677 (Drug)
Placebo
干预措施: BYK324677 (Drug)
结局指标
主要结局
Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
时间窗: during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)
Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ \[=PR\], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.
次要结局
- Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.(during Treatment Period 1 and Period 2 (up to 3 weeks))
- Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.(during Treatment Period 1 and Period 2 (up to 3 weeks))