A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers
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
- Change in raltegravir Area under the curve (AUC)0-12h
研究概览
简要总结
This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.
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
- All
- 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.
- •≥ 18 years
- •Male or female subjects
- •A female may be eligible to enter and participate in the study if she:
- •Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
- •Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy
- •Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication
- •Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)
- •Any intrauterine device (IUD) with published data showing that the expected failure rate is < 1 % per year
- •Any other method with published data showing that the expected failure rate is < 1 % per year
- •Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study
- •Male subjects with a female partner of childbearing potential must agree to use effective contraception as above unless vasectomized
- •All subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom)
排除标准
- •Any significant acute or chronic medical condition
- •Pregnant or lactating women
- •Women of childbearing age unless using non hormonal contraception
- •Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
- •Abnormal LFTs (ALT > 2.5 x ULN, bilirubin > 1.5 x ULN)
- •Positive blood screen for HIV-1 and 2 antibodies
- •Positive blood screen for hepatitis B or C antibodies
- •Current or recent (within 3 months) gastrointestinal disease
- •Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects
- •Use of proton pump inhibitors
- •Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
- •Consumption of grapefruit and oranges or products containing grapefruit or oranges within 1 week of first study drug and for the duration of the study
- •Use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug
- •Previous allergy to any of the constituents of the pharmaceuticals in this trial
研究组 & 干预措施
Raltegravir plus Maalox Plus
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days.
干预措施: Raltegravir 400 mg (Drug)
Raltegravir plus Maalox Plus
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days.
干预措施: Multivitamins (Dietary Supplement)
Raltegravir plus Maalox Plus
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days.
干预措施: Maalox Plus extra (Drug)
Raltegravir plus Multivitamin
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days.
干预措施: Multivitamins (Dietary Supplement)
Raltegravir plus Multivitamin
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days.
干预措施: Maalox Plus extra (Drug)
Raltegravir plus Sodium bicarbonate
Subjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days.
干预措施: Multivitamins (Dietary Supplement)
Raltegravir plus Sodium bicarbonate
Subjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days.
干预措施: Maalox Plus extra (Drug)
Raltegravir plus Sodium bicarbonate
Subjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days.
干预措施: Raltegravir 400 mg (Drug)
Raltegravir plus Multivitamin
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days.
干预措施: Raltegravir 400 mg (Drug)
Raltegravir plus Maalox Plus
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus multivitamin (1 tablet), raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose on five separate days.
干预措施: Sodium bicarbonate (Dietary Supplement)
Raltegravir plus Sodium bicarbonate
Subjects will be dosed with raltegravir 400 mg followed by raltegravir plus sodium bicarbonate 1 g, raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir 400 mg plus multivitamin (1 tablet), on five separate days.
干预措施: Sodium bicarbonate (Dietary Supplement)
Raltegravir plus Multivitamin
Subjects will be dosed with raltegravir 400 mg followed by raltegravir 400 mg plus multivitamin (1 tablet), raltegravir 400 mg plus Maalox Plus 30 mL, raltegravir 400 mg plus Maalox Plus 2h prior to raltegravir dose, raltegravir plus sodium bicarbonate 1 g on five separate days.
干预措施: Sodium bicarbonate (Dietary Supplement)
结局指标
主要结局
Change in raltegravir Area under the curve (AUC)0-12h
时间窗: Day 1, 6, 11, 16 and 21
The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin
Change in Raltegravir Area Under the Curve (AUC)0-12h
时间窗: Day 1, 6, 11, 16 and 21, over dosing period of 0-12 h
The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin. Data collected at the following time points: pre dose, 1, 2, 3, 4, 6, 8 10 and 12 h post dose on Days 1, 6, 11, 16 and 21.
次要结局
- Measurement of gastrointestinal pH(Day 1, 6, 11, 16 and 21)
- Number of adverse events(Day 1 up to end of study Day 27)
- Measurement of Gastrointestinal pH(Day 1, 6, 11, 16 and 21, four hours post dose)
- Number of Adverse Events(Day 1 up to end of study Day 27)
研究者
Helen Reynolds
Research nurse
University of Liverpool