A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
研究概览
简要总结
Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 participants between 18 and 65 years of age inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Healthy, i.e. not suffering from an acute or chronic illness and not using medications.
- •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.
- •Participant must practice a reliable method of birth control while they are participating in the study; for instance an intrauterine device (IUD), condom with spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal ligation, hysterectomy or abstinence or female must be post menopausal for at least one year.
排除标准
- •Have serological evidence of exposure to HIV
- •Female patients of childbearing potential who has a positive urine pregnancy test at screening
- •Participants not willing to use a reliable method of barrier contraception during the study.
- •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.
- •Participants taking oral contraceptive medications.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •Patients may be excluded from the study for other reasons, at the investigator's discretion.
研究组 & 干预措施
Maraviroc
Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin
Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily
Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily
干预措施: Rifabutin (Drug)
Maraviroc
Two period pharmacokinetic drug-drug interaction Period one -Maraviroc alone; Period two -Maraviroc and Rifabutin
Substance: Maraviroc (Celsentri, MVC) tablets, 300 mg; dose: oral, 300 mg (1 tablet) twice daily
Substance: Rifabutin (mycobutin, RFB) capsules, 150 mg; dose: oral, 300 mg (2 capsules) once daily
干预措施: Maraviroc (Drug)
结局指标
主要结局
Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24
时间窗: Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour..
Maraviroc pharmacokinetics: Maraviroc only AUC (h\*μg/L), Maraviroc + Rifabutin AUC (h\*μg/L), Rifabutin AUC (h\*μg/L), 25-O-desacetyl rifabutin AUC (h\*μg/L).
Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.
时间窗: Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour..
Maraviroc + Rifabutin pharmacokinetics: Maraviroc only Cmax (μg/L), Maraviroc only C12 (μg/L), Maraviroc + Rifabutin Cmax (μg/L), Maraviroc + Rifabutin C12 (μg/L), Rifabutin Cmax (μg/L), Rifabutin C24 (μg/L), 25-O-desacetyl rifabutin Cmax (μg/L), 25-O-desacetyl rifabutin C24 (μg/L).
次要结局
- Safety/Tolerability of the Treatments(30 days)