NCT02140268已完成1 期
A Phase 1, Single-center, Fixed-sequence, Open Label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Ardelyx
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics of midazolam when administered after AZD1722 by assessment of area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of midazolam
研究概览
简要总结
A Study to Evaluate the Effects of oral repeated doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers
详细描述
A Phase 1, Single-center, Fixed-sequence, Open Label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Midazolam in Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) ≥18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg. Females of non-childbearing potential must be postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range or documentation of irreversible surgical sterilization by hysterectomy, bilateraloophorectomy or bilateral salpingectomy but not tubal ligation
- •Females of childbearing potential must have a negative pregnancy test at screening, Day -1, and Day 14 and must not be lactating and use effective contraceptive methods to avoid pregnancy during the treatment period
- •Male healthy volunteers with a partner of childbearing potential must agree to avoid fathering a child, and refrain from donating sperm, from the first day of dosing until at least 3 months after last dose of the investigational product, and therefore be either sterile or agree to use approved methods of contraception
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the principal investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study. History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. Loose stools (BSFS of 6 or 7) ≥2 days in the past 7 days before investigational product administration. Use of medications that are known to affect stool consistency and/or GI motility, including fiber supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements, or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before the investigational product administration. Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins and minerals during the 2 weeks prior to the first administration of investigational product or longer if the medication has a long half-life. Use of drugs or substances with enzyme-inducing properties within 4 weeks prior to the first administration of investigational product.
研究组 & 干预措施
Midazolam 7.5 mg
Active Comparator
Volunteers will receive Midazolam 7.5 mg administered by mouth as a syrup
干预措施: Midazolam (Drug)
AZD1722 15 mg
Experimental
Volunteers will received AZD1722 15 mg administered by mouth, as a tablet
干预措施: AZD1722 (Drug)
AZD1722 15 mg and Midazolam 7.5 mg
Experimental
Volunteers will receive AZD1722 15 mg tablet and Midazolam 7.5 mg syrup, by mouth
干预措施: AZD1722 and Midazolam (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of midazolam when administered after AZD1722 by assessment of area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of midazolam
时间窗: Blood samples are collected predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 15 and 24 hours post dose on Day 1 and Day 15
Change in plasma area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of midazolam after AZD1722 administration
次要结局
- To evaluate the pharmacokinetics of midazolam metabolites when administered after AZD1722 by assessment of area under the concentration-time curve (AUC) maximal plasma concentration (Cmax) of 1-OH-midazolam and 4-OH-midazolam(Blood samples are collected predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 15 and 24 hours post dose on Day 1 and Day 15)
- • To evaluate the pharmacokinetics of the metabolites 1-OH-midazolam and 4-OH-midazolam when midazolam is administered after AZD1722 by assessment of AUC and Cmax of 1-OH-midazolam and 4-OH-midazolam(Blood samples are collected predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 15 and 24 hours post dose on Day 1 and Day 15)
- To evaluate the pharmacodynamic outcomes of AZD1722 by assessment of how AZD1722 effects stool consistency and frequency(Stool frequency and stool consistency will be measured daily (Day -1 through Day 16))
- To evaluate the plasma concentrations of AZD1722(Blood samples are collected predose, 1, 2, 4 hours post morning dose on Day 15)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
AZD7325 Multiple Ascending Dose StudyHealthy VolunteerNCT00681915AstraZeneca48
已完成
1 期
A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid TumorsAdvanced Solid TumorNCT00502567AstraZeneca104
已完成
1 期
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.Healthy VolunteersNCT01951599AstraZeneca35
已完成
1 期
To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy VolunteersHealthy VolunteersNCT02140281Ardelyx71
已完成
1 期
AZD8529 Multiple Ascending Dose Study in Healthy SubjectsHealthy VolunteerNCT00765492AstraZeneca47