NCT02253940已完成1 期
An Open-label, Randomized, Crossover Relative BA Study of Pharmacokinetics and Safety of New SDS-containing Tablet and Capsule Formulations of BILR 355 Compared to the Current Formulation (50 mg Tablet), After Single Dose Oral Administration of BILR 355 Plus Low Dose Ritonavir in Healthy 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
- 40
- 主要终点
- AUC0-inf (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy HIV negative adult male volunteers
- •Age ≥18 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
- •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 was deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (>24 hours) within at least one month prior to study drug administration and 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
- •Participation in another trial with an investigational drug within two months prior to administration or during the trial
- •Current smoker
- •Alcohol abuse (more than 60 g/day)
- •Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
- •Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
- •Excessive physical activities (within one week prior to study drug administration or during the trial)
- •Any laboratory value outside the reference range that was of clinical relevance at screening, according to the judgment of the investigator
- •Inability to comply with dietary regimen required by the protocol
- •Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
研究组 & 干预措施
Dose Group 1 - low dose
Experimental
Treatment sequences ABC / CAB / BCA
干预措施: BILR 355 - Treatment A (current tablet formulation) (Drug)
Dose Group 1 - low dose
Experimental
Treatment sequences ABC / CAB / BCA
干预措施: BILR 355 - Treatment B (new tablet formulation) (Drug)
Dose Group 1 - low dose
Experimental
Treatment sequences ABC / CAB / BCA
干预措施: BILR 355 - Treatment C (new capsule formulation) (Drug)
Dose Group 1 - low dose
Experimental
Treatment sequences ABC / CAB / BCA
干预措施: Ritonavir (Drug)
Dose Group 2 - high dose
Experimental
Treatment sequences DE / ED
干预措施: BILR 355 - Treatment D (current tablet formulation) (Drug)
Dose Group 2 - high dose
Experimental
Treatment sequences DE / ED
干预措施: BILR 355 - Treatment E (new capsule formulation) (Drug)
Dose Group 2 - high dose
Experimental
Treatment sequences DE / ED
干预措施: Ritonavir (Drug)
结局指标
主要结局
AUC0-inf (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: up to 96 hours after drug administration
Cmax (maximum measured concentration of analyte in plasma)
时间窗: up to 96 hours after drug administration
次要结局
- t1/2 (terminal half-life of the analyte in plasma)(up to 96 hours after drug administration)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 96 hours after drug administration)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(up to 96 hours after drug administration)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(up to 96 hours after drug administration)
- Number of subjects with adverse events(up to 12 days following last drug administration)
- Number of subjects with abnormal changes in laboratory parameters(up to 48 hours after drug administration)
研究者
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