NCT02253914已完成1 期
An Investigator Blinded, Randomized, Placebo-controlled Multiple Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)
研究概览
简要总结
Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.
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
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males who meet the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- •No finding deviating from normal (except as noted below) and of clinical relevance
- •No evidence of a clinically relevant concomitant disease
- •Age ≥18 years and <60
- •BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •Current and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (>24 hours) within one month prior to administration of study drug or during the trial
- •Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
- •Participation in another trial with an investigational drug within one month prior to administration or during the trial
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (more than 60 g/day)
- •Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- •Excessive physical activities (within 1 week prior to administration or during the trial)
- •Any laboratory value outside the normal reference range that is of clinical relevance
- •Inability to comply with dietary regimen of study centre
- •Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody positive)
- •HIV-1 infected as defined by a positive HIV ELISA test
研究组 & 干预措施
BILR 355 BS, tablet
Experimental
escalating doses
干预措施: Ritonavir (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BILR 355 BS, solution
Experimental
escalating doses
干预措施: BILR 355 BS, solution (Drug)
BILR 355 BS, solution
Experimental
escalating doses
干预措施: Ritonavir (Drug)
BILR 355 BS, tablet
Experimental
escalating doses
干预措施: BILR 355 BS, tablet (Drug)
结局指标
主要结局
AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)
时间窗: up to day 11
Cmax (maximum concentration of BILR 355 in plasma)
时间窗: up to day 11
Time for BILR 355 BS to achieve steady state
时间窗: up to day 11
Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)
时间窗: up to day 11
Incidence of dose limiting toxicity
时间窗: up to day 21
次要结局
- tmax (time from dosing to the maximum concentration of BILR 355 in plasma)(up to day 11)
- AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)(up to day 11)
- Cmax (maximum concentration of metabolite 402 in plasma)(up to day 11)
- Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)(up to day 11)
- Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)(up to day 11)
- Number of subjects with adverse events(up to 42 days)
研究者
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