NL-OMON49954已完成不适用
A Double-Blind, Placebo-Controlled, Randomized, Single-Center, Cross-Over Study to Investigate the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol. - Padsevonil interaction study with ethanol or cannabidiol
CB Pharma0 个研究点目标入组 44 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
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 99（—）
入选标准
- •- Participant must be 18 to 55 years of age inclusive, at the time of signing
- •the informed consent.
- •- Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, and cardiac
- •monitoring.
- •- Participant must have previous experience with alcohol consumption and,
- •therefore, must be familiar with the effects and able to tolerate social
- •amounts of alcohol.
- •- Participant has a body weight of at least 50 kg (males) or 45 kg (females)
- •and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive)
- •- Participants are male or female:
- •A male participant must agree to use contraception as detailed in the
- •protocol during the treatment period and for at least 7 days after the last
- •dose of study treatment and refrain from donating sperm during this period
- •A female participant is eligible to participate if she is not pregnant,
- •not breastfeeding, and at least 1 of the following conditions applies:
- •+Not a woman of childbearing potential (WOCBP) as defined n
- •the protocol
- •+A WOCBP who agrees to follow the contraceptive guidance in
- •the protocol during the Treatment Period and for at least 90 days after the
- •last dose of study treatment.
- •-Participant must be capable of giving signed informed consent as described in
- •Appendix 1 (Section 10.1), which includes compliance with the requirements and
- •restrictions listed in the informed consent form (ICF).
- •- Participant must be considered reliable and capable of adhering to the
- •protocol, according to the judgment of the Investigator, and is capable of
- •communicating satisfactorily with the Investigator.
排除标准
- •-Participant has any medical or psychiatric condition that, in the opinion of
- •the Investigator, could jeopardize or would compromise the study participant*s
- •ability to participate in this study, such as a history of schizophrenia, or
- •other psychotic disorder, bipolar disorder, or severe unipolar depression. The
- •presence of potential psychiatric exclusion criteria will be determined based
- •on the psychiatric history collected at the Screening Visit.
- •- Participant has history or presence of cardiovascular, respiratory, hepatic,
- •renal, gastrointestinal, endocrinological, hematological, or neurological
- •disorders capable of significantly altering the absorption, metabolism, or
- •elimination of drugs; constituting a risk when taking the study intervention;
- •or interfering with the interpretation of data
- •- Participant has a history of chronic alcohol or drug abuse within the
- •previous 6 months or the presence of drug or alcohol dependency at Screening or
- •Day -1 or tests positive for alcohol and/or drugs at Screening or Day -1
- •-Participant has a positive prestudy drug screen (to include at minimum:
- •amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines).
- •- Participant has a known hypersensitivity to any components of the study
- •medication or comparative drugs (and/or an investigational device) as stated in
- •this protocol
- •-Participant has abnormal blood pressure.
- •-Participant has a lifetime history of suicide attempt (including an actual
- •attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation
- •in the past 6 months as indicated by a positive response (*Yes*) to either
- •Question 4 or Question 5 of the *Screening/Baseline* version of the C-SSRS at
- •- Participant has a history of unexplained syncope or a family history of
- •sudden death due to long QT syndrome
- •- Participant has lymphoma, leukemia, or any malignancy within the past 5 years
- •except for basal cell or squamous epithelial carcinomas of the skin that have
- •been resected with no evidence of metastatic disease for 3 years
- •- Participant has past or intended use of over-the-counter or prescription
- •medication including herbal medications within 2 weeks or 5 half-lives prior to
- •dosing. Specific mediactions listed in section 6.5.1. may be allowed.
- •- Participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids,
- •phenobarbital, isoniazid, phenytoin, rifampicin etc.) within 2 months prior to
- •dosing. In case of uncertainty, the Medical Monitor should be consulted.
- •- Participant has previously received PSL in this or any other study.
- •- Participant has participated in another study of an IMP (and/or an
- •investigational device) within the previous 30 days of Screening or 5
- •half-lives whichever is longer or is currently participating in another study
- •of an IMP (and/or an investigational device).
- •- Participant has alanine transaminase (ALT), aspartate aminotransferase (AST),
- •or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN)
- •- Participant has bilirubin >1.0xULN (isolated bilirubin >1.0xULN is acceptable
- •if bilirubin is fractionated and direct bilirubin <35%).
- •- Participant has current or chronic history of liver disease or known hepatic
- •or biliary abnormalities (with the exception of Gilbert's syndrome or
- •asymptomatic gallstones)
- •- Participant has any clinically
研究者
相似试验
已完成
1 期
A Study of JNJ-75220795 in Japanese ParticipantsFatty LiverJPRN-jRCT2071210066akano Masayoshi27
进行中（未招募）
不适用
A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who SmokeEUCTR2007-005695-14-GBWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development30
终止
1 期
A Study of AB-161 Following Oral Administration in Healthy SubjectsHepatitis BInfection - Other infectious diseasesACTRN12623000074695Arbutus Biopharma Corporation20
已完成
1 期
A Phase I Study to evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic profile of single and multiple dose of ANB019 in Healthy Subjects and Psoriasis Patients.Plaque PsoriasisACTRN12617000369325AnaptysBio Pty Ltd87
已完成
1 期
A Single and Multiple Dose Study to Determine the Safety and Tolerability of GBT021601 in Healthy Adult Volunteers - Part ABlood - Haematological diseasesHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersSickle Cell DiseaseACTRN12620001324909inear Clinical Research Ltd64