NCT01549496撤回1 期
A Drug Interaction Study Investigating the Effect of Boceprevir on the Pharmacokinetics of the Calcium Channel Blockers Amlodipine and Diltiazem and Vice Versa in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to sign informed consent prior to any study-related activities.
- •Male or female subjects between 18 and 65 years of age inclusive.
- •Healthy, i.e. not suffering from a relevant acute or chronic illness.
- •Body Mass Index (BMI) of 17.5 to 31 kg/m2; and a total body weight > 50 kg (110 lbs).
- •Acceptable medical history, physical examination, and 12-lead ECG at screening.
- •Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
- •Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
- •Willingness to abstain from alcohol use for 3 days prior to and during the study.
- •Female subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- •Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- •A vasectomized partner
- •Total abstinence from sexual intercourse
排除标准
- •Have serological evidence of exposure to HIV or HCV.
- •Known allergies to any of the study medications.
- •Female subjects of childbearing potential who:
- •Has a positive urine pregnancy test at screening.
- •Is not willing to use a reliable method of barrier contraception during the study.
- •Using only oral contraceptive as a birth control method.
- •Is breastfeeding.
- •Inability to adhere to protocol.
- •Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
- •Female subjects using contraceptives that contain drospirenone.
- •Subjects that are currently smoking.
- •Subjects with hypertension or heart disease requiring medical treatment.
- •Any condition possibly affecting drug absorption (e.g., gastro intestinal disorder).
- •Patients may be excluded from the study for other reasons, at the investigator's discretion.
研究组 & 干预措施
boceprevir
Experimental
boceprevir 800 mg tid
干预措施: Amlodipine (Drug)
boceprevir
Experimental
boceprevir 800 mg tid
干预措施: Diltiazem (Drug)
结局指标
主要结局
pharmacokinetics
时间窗: 7 days
AUC, Cmax, Cmin
次要结局
- number of participants with adverse events(29 days)
研究者
研究点 (1)
Loading locations...
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