NCT02257021已完成1 期
Study of Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir
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
- 34
- 主要终点
- Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)
研究概览
简要总结
To determine the effect of BILR 355/r on tipranavir/r pharmacokinetics and the effect of tipranavir/r on BILR 355 BS pharmacokinetics
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
- None
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥19 and <60 years
- •BMI ≥18.5 and BMI ≤29.9 kg/m2
- •Ability to give signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local regulations
排除标准
- •Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •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 (review with clinical monitor if questionable)
- •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 (review with clinical monitor if questionable)
- •Participation in another trial with an investigational drug within one month prior to administration or during the trial
- •Current smoker or smoked within the past 30 days
- •Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
- •Recent blood donation (more than 100 mL within 56 days prior to administration or during the trial)
- •Excessive physical activities (within 1 week prior to study drug administration or during the trial)
- •Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
- •Inability to comply with dietary regimen required by the protocol
- •Chronic or relevant acute infections
- •Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, 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 with low dose of ritonavir
Experimental
干预措施: BILR 355 BS (Drug)
Tipranavir and high dose of ritonavir plus BILR 355 BS
Experimental
干预措施: BILR 355 BS (Drug)
Tipranavir and high dose of ritonavir plus BILR 355 BS
Experimental
干预措施: Tipranavir (Drug)
Tipranavir and high dose of ritonavir plus BILR 355 BS
Experimental
干预措施: High dose of ritonavir (Drug)
BILR 355 BS with low dose of ritonavir
Experimental
干预措施: Low dose of ritonavir (Drug)
结局指标
主要结局
Maximum measured concentration of tipranavir and BILR 355 BS in plasma at steady state over a dosing interval τ (Cmax,ss)
时间窗: up to 18 days after start of treatment
Area under the concentration-time curve of tipranavir and BILR 355 BS in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
时间窗: up to 18 days after start of treatment
次要结局
- Maximum measured concentration of ritonavir in plasma at steady state over a dosing interval τ (Cmax,ss)(up to 18 days after start of treatment)
- Number of participants with clinically relevant changes in laboratory parameters(up to 28 days after start of treatment)
- Terminal half-life of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (t1/2,ss)(up to 18 days after start of treatment)
- Apparent clearance of BILR 355 BS, tipranavir and ritonavir in plasma following extravascular administration at steady state (CL/F,ss)(up to 18 days after start of treatment)
- Time from dosing to the maximum concentration of BILR 355 BS, tipranavir and ritonavir in plasma at steady state (tmax,ss)(up to 18 days after start of treatment)
- Apparent volume of distribution of BILR 355 BS, tipranavir and ritonavir during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)(up to 18 days after start of treatment)
- Area under the concentration-time curve of ritonavir in plasma over one dosing interval (12 hours), (AUC0-12h)(up to 18 days after start of treatment)
- Number of participants with clinically relevant changes in vital signs (blood pressure, pulse rate)(up to 28 days after start of treatment)
- Number of participants with adverse events(Up to 7 weeks)
- Measured concentration of BILR 355 BS, tipranavir and ritonavir in plasma 12 hours post last dose at steady state (Cp12h,ss)(up to 18 days after start of treatment)
- Number of participants with clinically relevant changes in 12-lead ECG(up to 14 days after start of treatment)
研究者
相似试验
已完成
1 期
Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir in Healthy VolunteersHealthyNCT02253901Boehringer Ingelheim33
已完成
1 期
Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy SubjectsHealthyNCT02256774Boehringer Ingelheim51
已完成
1 期
Pharmacokinetics of Atorvastatin With Tipranavir/Ritonavir and the Effect of Antacid on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir in Healthy VolunteersHealthyNCT02245269Boehringer Ingelheim23
已完成
不适用
Pharmacokinetic Interactions Between Buprenorphine and Tipranavir/RitonavirHIV InfectionsNCT00486330Yale University12
已完成
1 期
Comparison of the Effect of Tipranavir and Ritonavir or Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Zidovudine in Healthy VolunteersHealthyNCT02249416Boehringer Ingelheim60