NL-OMON55261已完成不适用
Randomized, Double-Blind, Double-Dummy, Placebo-Controlled 4-way Crossover Study to assess the Pharmacodynamics and Pharmacokinetics of Oral and Intravenous S-Ketamine in Healthy Volunteers - PKPD of Oral vs IV S-Ketamine in HV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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. Healthy female or male subjects, 18 to 45 years of age, inclusive. Healthy
- •status is defined by absence of evidence of any active or chronic disease
- •following a detailed medical, surgical and psychiatric history, a complete
- •physical examination including vital signs, 12-lead electrocardiogram (ECG),
- •haematology, blood chemistry, and urinalysis.
- •2. Able to participate and willing to give written informed consent and to
- •comply with the study restrictions.
- •3. Use of any form of birth control is required for heterosexual subjects of
- •childbearing potential who are sexually active during the study, either used by
- •the subject or their sexual partner.
- •4. Able to read and understand English at a sufficient level in order to
- •participate in the ETB.
排除标准
- •1. Positive test for drugs of abuse at screening or pre-dose.
- •2. The subject has a positive pregnancy test.
- •3. History (within 3 months of screening) of alcohol consumption exceeding 2
- •standard drinks per day on average.
- •4. History or symptoms of any significant disease including (but not limited
- •to), neurological, endocrine, cardiovascular, respiratory, gastrointestinal,
- •hepatic, or renal disorder.
- •5. The subject has a previous or current, or a family history of, a clinically
- •significant psychiatric disorder, including substance use disorder.
- •6. A history or family history of epilepsy, seizures or convulsions.
- •7. Having metal objects in brain or skull.
- •8. The subject has a history of intracranial mass lesion, hydrocephalus and/or
- •head injury or trauma.
- •8. Having a cochlear implant or implanted deep brain stimulator.
- •9. Abnormal sleeping pattern (e.g. working night shifts).
- •10. Resting motor threshold (rMT) of more than 75% of the maximum stimulator
- •output, measured using TMS-EMG during screening.
- •11. Systolic blood pressure (SBP) greater than 140 mmHg during screening. The
- •measurement may be repeated before randomization to confirm eligibility or
- •judged to be clinically irrelevant for healthy subjects.
- •12. Use of any medications within 14 days of study drug administration, or less
- •than 5 half-lives (whichever is longer).
- •13. Use of more than 5 cigarettes (or other tobacco or nicotine products with
- •equivalent nicotine dose) daily within the previous month before the first dose
- •administration, and/or unable or unwilling to not smoke during the in-house
- •15. Regular recreational use of illicit drugs (notably ketamine) within 12
- •months of screening.
研究者
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