A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE BITOPERTIN ON SINGLE DOSE PHARMACOKINETICS OF MIDAZOLAM IN HEALTHY VOLUNTEERS
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
研究概览
简要总结
This will be a single-center, open-label, inpatient/outpatient, fixed-sequence study examining the effect of multiple doses of bitopertin on single doses of Midazolam in healthy volunteers.
A single oral dose on Midazolam (7.5 mg) will be administered on Day 1 after an overnight fast. Daily oral doses of bitopertin will be given under fed conditions from Days 2-13 and after fasting on Day 14. Oral doses of bitopertin and Midazolam (7.5 mg) will be co-administered on Day 15, after an overnight fast.
Pharmacokinetics will be assessed throughout. Total time on treatment is expected to be 15 days.
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
- 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
- •Healthy male and female volunteers, 18 to 65 years of age, inclusive.
- •A BMI between 18 to 30 kg/m2, inclusive.
- •Healthy as determined by the Investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs and 12-lead electrocardiogram (ECG)
- •Female participants must use effective contraception as defined by the protocol and cannot be pregnant or breastfeeding
- •Non-smoker or smoker of fewer than 10 cigarettes per day
- •Must be able to refrain from smoking during the in-patient stay
排除标准
- •Personal or family history of congenital long QT syndrome or family history of sudden death
- •Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days prior to study start
- •History of alcoholism, drug abuse or addiction within the last year prior to study start, or suspicion of drug abuse/addiction or alcohol use prior to study start
- •Current alcohol consumption averaging more than 24 g of alcohol per day
- •Any significant allergic reactions against any drug, or multiple allergies in the judgment of the Investigator
研究组 & 干预措施
bitopertin-Midazolam
干预措施: Midazolam (Drug)
bitopertin-Midazolam
干预措施: bitopertin (Drug)
结局指标
主要结局
Change in plasma area under the concentration-time curve (AUC) of midazolam after bitopertin administration
时间窗: Days 1 and 15
次要结局
- Change in 1'-hydroxymidazolam plasma AUC after bitopertin administration(Days 1 and 15)
- Incidence of adverse events(Approximately 76 days)