NL-OMON28424尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 16
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
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 periods.
- •15. Regular recreational use of illicit drugs (notably ketamine) within 12 months of screening.
研究者
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