Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400mg, 800mg, 1200mg) of BI 207127 NA in Healthy Male Asian Volunteers and Single Oral Dose (1200 mg) of BI 207127 NA in Healthy Male Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Group)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Subjects With Drug Related Adverse Events
研究概览
简要总结
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 207127 NA (low dose)
Single dose of BI 207127 NA
干预措施: BI 207127 NA (low dose) (Drug)
Matching placebo (low dose)
Single dose of matching placebo
干预措施: Matching placebo (low dose) (Drug)
BI 207127 NA (medium dose)
Single dose of BI 207127 NA
干预措施: BI 207127 NA (medium dose) (Drug)
Matching placebo (medium dose)
Single dose of matching placebo
干预措施: Matching placebo (medium dose) (Drug)
BI 207127 NA (high dose)
Single dose of BI 207127 NA
干预措施: BI 207127 NA (high dose) (Drug)
Matching placebo (high dose)
Single dose of matching placebo
干预措施: Matching placebo (high dose) (Drug)
结局指标
主要结局
Number of Subjects With Drug Related Adverse Events
时间窗: From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.
Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint. The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history.
Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG
时间窗: From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.
Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint. New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure).
次要结局
- AUC0-∞ of Deleobuvir(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration)
- Tmax of Deleobuvir(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Cmax of Deleobuvir(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Tmax of BI 208333 (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Cmax of BI 208333 (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Tmax of CD 6168 (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Cmax of CD 6168 (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)
- Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)(-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration)