A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t
研究概览
简要总结
The purpose of this study is to evaluate the effect of repeated doses of oral delafloxacin on the pharmacokinetic (PK) profile of a single oral dose of midazolam.
详细描述
This study will evaluate the effect of repeated doses of oral delafloxacin on the PK profile of a single oral dose of midazolam. The study will also evaluate the pharmacokinetics, safety, and tolerability of repeated oral doses of delafloxacin in healthy male and female subjects and to obtain a steady state PK profile for oral delafloxacin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No clinically important abnormal physical findings.
- •No clinically significant laboratory abnormalities.
- •Normal (or abnormal but not clinically significant) ECG measurements.
- •Body mass index between 18.0 and 32.0 kg/m
- •Normal (or abnormal but not clinically significant) blood pressure and pulse rate measurements. methylxanthine-containing beverages or food
- •Non-smoker
排除标准
- •Received any investigational drug within 8 weeks before administration of the first dose of the study drug
- •Female who is pregnant, has a positive pregnancy test, or is breastfeeding.
- •Positive test result for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, opiates, cannabinoids, methylenedioxymethamphetamine, cotinine, or alcohol in urine at Screening or Day -
- •Positive screening test for hepatitis B surface antigen, hepatitis C, and/or human immunodeficiency virus antibodies.
- •Any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
- •Used any medication (prescription or over-the-counter, including health supplements and herbal remedies, with the exception of acetaminophen, as defined in exclusion number 8) within 2 weeks (4 weeks for drugs or substances known to inhibit or induce CYP enzymes and/or P-gp including St. John's wort [Hypericum perforatum]) or 5 half-lives (whichever is longer) before the first dose of study drug.
- •Used an oral or IV antibiotic within 4 weeks of administration of the first dose of the study drug.
- •Routinely or chronically used more than 2 g of acetaminophen daily.
- •Performed strenuous activity, sunbathing, and/or contact sports within 96 hours (4 days) before entry into the clinical study site on Day -1, and for the duration of the study.
- •Donated or lost greater than 400 mL of blood in the 30 days before administration of the first dose of the study drug.
- •History of clinically significant GI disease, or gastroenteritis (vomiting or diarrhea) or any history of GI bleeding (excluding bleeding from hemorrhoids)
- •History of any significant drug allergy
- •History of any drug or alcohol abuse in the past 2 years
研究组 & 干预措施
Midazolam/Delafloxacin
Each subject will receive a single 5 mg oral dose of midazolam syrup on Day 1, oral 450 mg delafloxacin tablets twice daily (Q12h) for Days 3 to 8, and co-administered a single 5 mg oral dose of midazolam syrup in the AM on Day 8.
干预措施: Midazolam (Drug)
Midazolam/Delafloxacin
Each subject will receive a single 5 mg oral dose of midazolam syrup on Day 1, oral 450 mg delafloxacin tablets twice daily (Q12h) for Days 3 to 8, and co-administered a single 5 mg oral dose of midazolam syrup in the AM on Day 8.
干预措施: Delafloxacin (Drug)
结局指标
主要结局
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-t
时间窗: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: AUC0-inf
时间窗: Days 1 and 8
Midazolam and 1-hydroxymidazolam Plasma PK: Cmax
时间窗: Days 1 and 8
次要结局
未报告次要终点