NL-OMON45402
已完成
不适用
A Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Subjects. - JNJ-61393215 Phase I MAD study
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Anxiety and stress disorders
- 发起方
- Janssen-Cilag International NV
- 入组人数
- 36
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Healthy male subjects between 18 and 55 years of age, inclusive.;2\. Subjects must have a body mass index (BMI) between 18\.0 and 30\.0 kg/m2, inclusive
- •(BMI \= weight/height2\).;3\. Subject must be healthy on the basis of physical examination, medical history, vital signs, and 12\-lead ECG \[incl. QTcF \<\= 450 msec for males and \<\= 470 msec for females] performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator \[ICD] will lead to exclusion.;4\. Subjects must be healthy on the basis of 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 investigator.;5\. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of contraception e.g., either condom with spermicidal foam/gel/film/cream/suppository during the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug. All men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partner should also use a highly effective method of contraception for at least the same duration. Examples of highly effective contraceptives include implantable progestogen\-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone\-releasing system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the subject.), combined (estrogen\- and progestogen\-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen\-only hormone contraception associated with inhibition of ovulation: oral and injectable.;6\. Subjects must be willing to adhere to the prohibitions and restrictions specified in this protocol.;7\. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.;Specific exclusion criteria Part 2:
- •\- Healthy male and female subjects of non\-childbearing potential between 18 and 55 years of age, inclusive.;\- Before randomization, female subjects must be of non\-childbearing potential, defined as:
- •\* Postmenopausal
- •A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12
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, though minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable.;2\.1 Current or past history of any psychiatric disorder as classified according to DSM\-IV or DSM\-V.;3\.1 Subject has any liver function test (including ALT, AST, gGT, ALP and bilirubin) at screening exceeding 1\.5 times the upper limit of normal.;4\. Subject has estimated glomerular filtration rate (eGFR) \<60 mL/min/1\.73m2 at screening (provided by the local laboratory).;5\. Subject has a heart rate \< 50 bpm or \> 100 bpm or systolic blood pressure \>\= 150 mmHg at screening or at admission to the clinical unit.;Specific exclusion criteria Part 2:
- •\- Contraindications to the use of alprazolam per local prescribing information.;\- Subject has a personal or family history of sickle cell anaemia.;\- Subject has a history of benzodiazepines abuse and/or dependence.;\- Subject has a significant cardiovascular history, or suspicion of infarct, cardiomyopathy, cardiac failure, transient ischaemic attack, angina pectoris, cardiac arrhythmias, cerebrovascular accident.;\- Subject has a history of significant respiratory conditions, including asthma, lung fibrosis and non\-invalidating Chronic Obstructive Pulmonary Disease.;\- Subject has a personal or familial history of cerebral aneurysm.;\- Subject has hypertension (i.e. systolic pressure \>180 and/or diastolic pressure \>100mmHg).;\- Subject has epilepsy.
结局指标
主要结局
未指定
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