NL-OMON51575已完成不适用
Pharmacokinetics of the CYP3A substrate Midazolam after steady-state dosing of IMU-935. - PK of Midazolam after steady-state dosing of IMU-935.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Immunic AG
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Sex : male or female of nonchildbearing potential
- •2. Age : 18 to 65 years, inclusive, at screening
- •3. Body mass index : 18.0 to 32.0 kg/m2, inclusive, at screening
- •4. Weight : >=55 kg at screening
- •5. Status : healthy subjects per discretion of the Investigator
- •6. Female subjects must be of nonchildbearing potential (either surgically
- •sterilized or
- •physiologically incapable of becoming pregnant, or at least 1 year
- •postmenopausal
- •[amenorrhea duration of 12 consecutive months]) and have a negative serum
- •pregnancy test at screening and a negative urine pregnancy test at each
- •to the clinical research center.
- •7. Male subjects, if not surgically sterilized, must agree to use adequate
- •contraception and not donate sperm from first admission to the clinical
- •research center until 90 days after the follow-up visit. Adequate contraception
- •for the male subject (and his female partner, if she is of
- •childbearing potential) is defined as having his female partner using hormonal
- •contraceptives or an intrauterine device combined with the use of a condom by
- •the male subject for any sexual activity
- •Total abstinence, in accordance with the lifestyle of the subject, is also
- •acceptable.
- •8. All prescribed medication must have been stopped at least 30 days prior to
- •admission to the clinical research center.
- •9. All over-the-counter medication, vitamin preparations and other food
- •supplements,
- •or herbal medications (eg, St. John*s wort) must have been stopped at least
- •14 days prior to first admission to the clinical research center. An exception
- •for paracetamol, which is allowed up to admission to the clinical research
- •10. Ability and willingness to abstain from alcohol from 48 hours (2 days)
- •screening, each admission to the clinical research center, and follow-up, and
- •the stays in the clinical research center.
- •Further criteria apply, see protocol.
排除标准
- •1. Previous participation in the current study.
- •2. Employee of PRA or the Sponsor.
- •3. History of relevant drug and/or food allergies.
- •4. Patients with a history of acute angle-closure glaucoma or untreated
- •open-angle
- •5. Using tobacco products within 60 days prior to the first drug administration.
- •6. History of alcohol abuse or drug addiction (including soft drugs like
- •7. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
- •antidepressants, cotinine, and alcohol) at screening or at one of the
- •admissions to
- •the clinical research center.
- •8. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
- •approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
- •9. Estimated glomerular filtration rate calculated by the Chronic Kidney Disease
- •Epidemiology Collaboration creatinine equation <60 mL/min/1.73m2.
- •10. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus
- •antibodies, or HIV 1 and 2 antibodies.
- •Further criteria apply, see protocol.
研究者
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