NL-OMON54291已完成不适用
A 3-part study to investigate the safety, pharmacodynamics and pharmacokinetics of increasing doses of intravenously administered N,N-dimethyltryptamine (DMT) and deuterated DMT (CYB004) in healthy smokers and non-smokers - Safety, PK and PD of DMT and CYB004 in healthy smokers and non-smokers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
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 male and female volunteers.
- •2. Aged 21 - 60 years inclusive.
- •3. Part A: Regular use of nicotine (5-10 cigarettes daily).
- •Part B and C: non-smokers, defined as individuals who have never smoked
- •tobacco or used nicotine or tobacco containing products, or individuals with no
- •use of nicotine or tobacco containing products in the past 2 months.
- •4. Self-report of at least one prior hallucinogen drug experience that included
- •a meaningful altered state of consciousness (a state in which the subject
- •experienced phenomena that altered his psychological functioning, such as loss
- •of ego boundaries, impaired control of actions and cognition, disembodiment,
- •changed meaning of percepts, visual alterations and audio-visual synesthesia)
- •the past 5 years. Hallucinogenic substances can include psilocybin, LSD, DMT,
- •ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE) and/or
- •5. Participant has a body mass index (BMI) between 18.0 and 30.0 kg/m2
- •inclusive (BMI=weight/height2).
- •6. Subject must be healthy based on physical examination, medical history,
- •vital signs, and 12-lead ECG. Minor abnormalities in ECG, which are not
- •considered to be of clinical significance by the investigator, are acceptable.
- •7. Subjects must be healthy based on clinical laboratory tests performed at
- •screening. If the results of the serum chemistry panel, hematology, or
- •urinalysis are outside the normal reference ranges, the subject may be included
- •only if the investigator judges the abnormalities to be not clinically
- •significant. This determination must be recorded in the subject's source
- •documents and initialed by the sub investigator.*
- •8. Agree to refrain from using any psychoactive drugs, including alcoholic
- •beverages within 24 hours of each drug administration.
排除标准
- •1. Subject has a history of or current liver or renal insufficiency;
- •significant cardiac, vascular, pulmonary, gastrointestinal, endocrine,
- •neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances,
- •any inflammatory illness or any other illness, which are considered to be of
- •clinical significance by the investigator.
- •2. Clinically relevant abnormal history, physical finding,12-lead safety
- •ECG12-lead safety ECG (e.g. PQ/PR interval > 210ms, presence of Left Bundle
- •Branch Block (LBBB), AV Block (second degree or higher), or a permanent
- •pacemaker or implantable cardioverter defibrillator [ICD]), or laboratory value
- •at screening that could interfere with the objectives of the trial or the
- •safety of the volunteer.
- •3. Subject has a history of or current hypertension (systolic blood pressure
- •>140 mmHg or diastolic blood pressure >90 mmHg).
- •4. Presence or history of cardiovascular disease, including acute coronary
- •syndrome or angina, ischemic disease, ventricular arrhythmias or cardiac
- •transplantation as determined by self-report during review of medical history.
- •5. Subject has a history of chronic or frequent migraines.
- •6. Females of childbearing potential with positive urine pregnancy at screening
- •or the day of the first treatment.
- •7. Subject has a history of drug or alcohol use disorder according to DSM-IV or
- •DSM 5 within the past five years.
- •8. Subject has a positive test result(s) for alcohol and/or drugs of abuse
- •(including: opiates (including methadone), cocaine, amphetamines,
- •methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening
- •or admission to the clinical unit.*
- •9. Current or history of any clinically relevant psychiatric disorder as
- •classified according to DSM-IV or DSM 5 (e.g. psychotic disorder e.g.
- •schizophrenia/schizo-affective disorder, bipolar disorder Type I or Type II,
- •personality disorder, major depressive disorder/persistent depressive disorder,
- •obsessive-compulsive disorder, panic disorder, anorexia nervosa, bulimia
- •nervosa, generalized anxiety disorder (GAD), post-traumatic stress disorder
- •(PTSD) or autism spectrum disorder (ASD).
- •10. Family history of a relevant psychiatric disorder in first-degree
- •relatives. Psychiatric history in second degree relatives will be discussed on
- •a case to case basis.
- •11. Persistent psychological effects following the previous use of psilocybin,
- •LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE)
- •and/or ketamine. Such effects might include but are not limited to anxiety,
- •depressed mood, paranoid ideation and/or hallucinations (including hallucinogen
- •persisting perception disorder - HPPD) or recurrent flash-backs related to use.
- •12. Risk of suicide, as judged by an Investigator, based upon available source
- •information -including the C-SSRS or family history of suicide -indicating
- •current suicidal ideation or a history of active suicidal ideation or suicide
- •13. Positive SARS-CoV-2 rapid antigen test analysis prior to first dosing.
研究者
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