A Phase I Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Boceprevir and Sildenafil When Dosed Separately and Together in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Boceprevir Alone Maximum Plasma Concentration
研究概览
简要总结
This is a healthy volunteer study looking at the interactions between two drugs: boceprevir and sildenafil.
New drugs are being developed to treat people with the chronic viral infection hepatitis C. Very little is know how these new treatments interact with other medications such as the drugs used to treat erectile dysfunction.
The purpose of this study is to look at levels of both a new hepatitis C drug called boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they affect the blood levels of each other when given separately and together.
详细描述
Total duration for each participant will be up to 40 days plus a screening visit 1 - 3 weeks prior to the start of the study.
They will visit the clinic on 10 occasions: screening visit, baseline visit (day 0), day 1, a visit between day 4 and 7, day 10, day 14, day 15, day 16, day 17 and a follow up visit between days 26 and 40.
The total amount of blood collected from participants during the entire study will be no greater than 350 ml in total (around 23 tablespoons).
At the screening visit a clinical assessment will be performed. At the baseline visit participants will attend the clinic fasted and will be required to remain on the unit for approximately 14 hours.
On the morning of the visit clinical assessments will be performed. Sildenafil 25mg (1 tablet) will be administered with a standardised meal. Blood samples will be taken at the following times in order to measure the levels of sildenafil in the blood: predose,0.5, 1, 2, 3, 4, 6, 8, 10,12 and 24 hours post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- •Subjects in good health upon medical history, physical exam, and laboratory testing and BMI <
- •Subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 10 days following last dose of study drug.
- •Have no serologic evidence of HIV or HCV infection through antibody testing at screening.
- •Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical relevance
排除标准
- •Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
- •Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
- •Clinically relevant alcohol or drug use (positive drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
- •Any medication taken listed in protocol including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
- •History of drug sensitivity or drug allergy which in the opinion of the investigator may put the subject at increased risk of drug reactions during the study.
- •Subjects with female partners who are pregnant will not be allowed to enter the study
研究组 & 干预措施
Sildenafil and Boceprevir
Healthy volunteers
干预措施: Sildenafil and Boceprevir (Drug)
结局指标
主要结局
Boceprevir Alone Maximum Plasma Concentration
时间窗: day 10-15
Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)
Sildenafil Alone Maximum Plasma Concentration
时间窗: Day 1
Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)
Sildenafil Maximum Plasma Concentration
时间窗: Day 16
administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)
Boceprevir Maximum Plasma Concentration
时间窗: Day 16
administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)
次要结局
- Number of Patients With Adverse Events(Day 1 - 16)