NL-OMON42183已完成不适用
A 2-part randomized, three-period cross-over, placebo controlled, proof of mechanism study to investigate the effect of RO5285119 on vasopressin (AVP) pathway activation in healthy male subjects - Effect of RO5285119 on vasopressin effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
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
- •1. Right-handed (Righthandedness as confirmed on the Edinburgh Handedness inventory), healthy non smoking male adults (18 - 45 years of age)
- •2. BMI between 18 to 32 kg/m2 (inclusive), total weight in the range of 50-100 kg.
- •3. Subjects and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose.
- •4. Able to participate and willing to give written informed consent and to comply with the study restrictions.
- •5. In the investigator*s opinion, the subject is deemed appropriate for participation in the study, capable of following the study schedule of assessments and complying with the study restrictions and discontinuation of prohibited medication will not pose undue risks to the
- •6. Minimally completed secondary education or equivalent
排除标准
- •1. No alcohol and substance abuse/dependance
- •2. History of relapsing or current psychiatric or neurological disorders, including epilepsy and migraine.
- •3. Subjects who, in the Investigator's judgment, pose a suicidal risk, or any subject with a history of suicidal attempts or behavior
- •4. Positive results for serology test for HIV, Hepatitis B, hepatitis C viruses
- •5. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
- •6. Pulse below 40 BMP or above 90 BPM
- •7. Clinically significant abnormality on electrocardiogram (ECG), including QTcF > 450 ms.
- •8. Clinically significant abnormality in parameters of clinical chemistry and urinalysis.
- •9. Active stomach ulcer disease or active GI bleeding.
- •10. Personal or family history (first or second degree relatives) of cerebral aneurysm.
- •11. Personal history of stroke or traumatic head injury.
- •12. Clinically significant abnormality in parameters of hematology or coagulation.
- •13. History of coagulopathies, bleeding disorders or blood dyscrasias.
- •14. History of hematological malignancy or myelosuppression (including iatrogenic).
- •15. Contraindications to have MRI scans (e.g. no metallic implants)
- •16. Use of prohibited medications within 2 weeks prior to randomization, or 5 half-lives (whichever is longer).
- •17. No participation in other trials within 90 days prior to enrollment or prior participation in part
- •A of study BP29412.
- •18. Donation or loss of blood over 500mL within three months prior to randomization
- •19. Chronic rhinitis, allergic rhinitis, nasal polyps or any other nasal pathology that may affect the absorption of intranasal AVP.
- •20. Concomitant disease, condition or treatment which might interfere with the
- •conduct of the study, or what would, in the opinion of the investigator,
- •pose an unacceptable risk to the subject in this study such as asthma or
- •ischemic events like Raynaud syndrome, angina pectoris or stroke.
- •21. unwilling to comply with lifestyles
- •22. Known allergic reaction to vasopressin or excipients present in the
- •formulation used in this study.
- •23. For Part B only: Contraindications for lumbar puncture:
- •- Any history of raised intra-cerebral pressure or clinically significant vertebral joint pathology.
- •- Clinically significant abnormalities in lumbar spine.
- •- Any major illness within one month prior to the screening examination, or febrile illness or any
- •- clinically significant infections within 21 days prior to CSF sampling.
- •- Thrombocytopenia or other bleeding diathesis (including ongoing anticoagulant therapy).
- •- Allergy to lidocaine.
- •- Any other spine abnormality that will not allow a lumbar puncture or other pathology that according
- •to the investigator*s judgment may interfere with the LP or may pose unacceptable risk for LP.
研究者
相似试验
进行中（未招募）
1 期
Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participantsPulmonary arterial hypertensionEUCTR2019-001699-12-GBGlaxoSmithKline Research and Development Ltd24
进行中（未招募）
不适用
A double-blinded, randomised, three-period crossover euglycaemic clamp trial investigating the pharmacokinetics, glucodynamics and safety of BC222 human insulin, human insulin (Huminsulin® Normal) and insulin lispro (Humalog®) in subjects with type 1 diabetesDiabetes mellitus type 1MedDRA version: 17.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2014-001432-11-DEAdocia
进行中（未招募）
1 期
A trial investigating liraglutide on the liver glucose production during induced hypoglycaemic in type 1 diabetes mellitussubjectsEUCTR2014-001381-96-ATMedizinische Universität Graz / Endokrinologie und Stoffwechsel
已完成
不适用
A study in healthy subjects to explore the blood levels of a drug when released from the IntelliCap capsule as compared to a marketed drug capsulePharmaceutical research and developmentISRCTN45336965Medimetrics Personalized Drug Delivery B.V. (Netherlands)14
已完成
1 期
An open-label, randomized, two-period crossover study to compare the pharmacokinetic and safety profile of single dose of TAK-070 (50 mg) under fed and fasting condition in healthy volunteerAlzheimer's diseases diseaseJPRN-UMIN000018040nit for Early and Exploratory Clinical Development, The University of Tokyo Hospital8