NL-OMON51826已完成不适用
A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, Parallel-Group Study to Evaluate the Effect of LMTM on the Response to an Oral Tyramine Challenge and to Determine the Multiple-Dose Pharmacokinetics of LMTM. - Tyramine challenge with LMTM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
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. Signature of an Independent Ethics Committee approved written informed
- •consent prior to any clinical study-related procedures.
- •2. Male or female subjects
- •2.1. Aged 18 to 60 years, inclusive (Tyramine Challenge Parts 1 and 2);
- •2.1.1. The goal will be to enroll approximately 12 or more subjects aged >=50
- •years in each part.
- •2.2. Aged >=50 years (PK Substudy).
- •3. Weighing between 50 and 110 kg, inclusive such that the body mass index
- •(BMI) is 18.5 to 32 kg/m2, inclusive.
- •4. In good health in the opinion of the PI as determined by:
- •4.1. Medical history;
- •4.2. Physical examination;
- •4.3. Vital signs assessment;
- •4.4. 12-lead electrocardiogram (ECG); and
- •4.5. Clinical laboratory evaluations.
- •5. If female, must meet one of the following:
- •5.1. Be permanently sterile, defined as at least 6 months following
- •hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
- •5.2. Have undergone bilateral tubal occlusion / ligation at least 6 months
- •prior to screening.
- •5.3. Be postmenopausal, defined as at least 12 months post cessation of menses
- •(without an alternative medical cause); postmenopausal status will be confirmed
- •with a screening serum follicle stimulating hormone (FSH) level greater than
- •33.4 mIU/mL.
- •5.4. Using adequate contraception and agree to do so throughout study
- •participation and for 90 days after the last dose of study drug; the following
- •are considered effective forms of birth control:
- •5.4.1. Hormonal contraceptives started at least 90 days prior to study drug
- •administration;
- •5.4.2. Intra-uterine contraceptive device (hormonal or non-hormonal) placed at
- •least 4 weeks prior to study drug administration;
- •5.4.3. Male condom;
- •5.4.4. Sterile male partner (vasectomized for at least 6 months); and
- •5.4.5. True abstinence (when this is in line with the preferred and usual
- •lifestyle of the subject).
- •6. If female, including those who have underwent hysterectomy, must agree to
- •not donate ova starting from Day -1 and throughout the clinical study period,
- •and for at least 28 days after the final study drug administration.
- •7. If male and sexually active with a female partner of childbearing potential
- •(childbearing potential females are defined as women who are neither
- •postmenopausal nor surgically sterile), must be willing to use one of the
- •following acceptable contraceptive methods from the first study drug
- •administration until at least 90 days after the last study drug administration:
- •7.1. Simultaneous use of a male condom and, for the female partner, hormonal
- •contraceptives used since at least 4 weeks or intra-uterine contraceptive
- •device placed since at least 4 weeks;
- •7.2. Simultaneous use of a male condom and, for the female partner, a diaphragm
- •or cervical cap.
- •8. If male, must agree to not donate sperm from Day -1 until 90 days after the
- •final study drug administration.
排除标准
- •1. If female, pregnant or lactating.
- •2. History of allergy/sensitivity to the following:
- •2.1. Phenelzine, selegiline, or other drugs of a similar class (Tyramine
- •Challenge Parts 1 and 2 only).
- •2.2. Methylthioninium (methylene blue) or similar organic dyes, as determined
- •2.3. Any of the excipients used in LMTM (which include mannitol, cellulose,
- •crospovidone, and magnesium stearate).
- •3. Clinically significant history of allergic conditions (including severe
- •hypersensitivity drug reactions, asthma, eczema or anaphylactic reactions, but
- •excluding untreated, asymptomatic seasonal allergies at the time of dosing), as
- •judged by the PI.
- •4. For Tyramine Challenge Parts 1 and 2 only, subject is unable to swallow the
- •capsule sizes used in this study.
- •5. Febrile illness or symptomatic viral, bacterial (including upper respiratory
- •infection), or fungal (noncutaneous) infection within 1 week prior to admission
- •to the clinical unit.
- •Further criteria apply, see protocol.
研究者
相似试验
已完成
1 期
A placebo and comparator controlled phase 1, safety and tolerability study of 3 ascending doses of INP105 (intranasal OLZ by I231 POD® device).Acute Agitation in SchizophreniaAcute Agitation in Bipolar I DisorderNeurological - Other neurological disordersMental Health - SchizophreniaACTRN12618000966291Clinical Network Services (CNS) Pty Ltd40
已完成
1 期
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GRX-917 in Healthy SubjectsMental Health - DepressionAnxietyACTRN12621000160831Gaba Therapeutics Australia Pty Ltd a subsidiary of Gaba Therapeutics, Inc102
已完成
1 期
A Study of Clofazimine Inhalation Suspension (MNKD-101) in Healthy VolunteersPulmonary Nontuberculous Mycobacteria InfectionsInfection - Other infectious diseasesACTRN12621001702808MannKind Corporation40
已完成
不适用
A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Paltusotine In Healthy SubjectsacromegalyNL-OMON51860Crinetics Pharmaceuticals, Inc.27
已完成
1 期
A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After a Single Dose and Multiple Doses in Healthy SubjectsACTRN12621000592842Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm)50