EUCTR2009-016732-12-GB进行中（未招募）不适用
An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers
MAP Pharmaceuticals, Inc.0 个研究点开始时间: 2010年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to provide written informed consent
- •2. Male or Female subjects 18 to 45 years old
- •3. Female subjects who are practicing adequate contraception or who are sterile
- •4. Stable cardiac status
- •5. Normal rhythm or arrhythmia deemed clinically insignificant on ECG
- •6. Heart rate = 40 and = 100 at Visit 1 vital signs assessment (resting)
- •7. QTcF (Fridericia’s Correction) = 450 msec
- •8. Non smokers: never smoked or total exposure <1 pack year and at least 12 months since last
- •cigarette with a negative urinary cotinine result at screening
- •9. Smokers: currently smoking at least 10 cigarettes/day for at least 1 year with a positive
- •urinary cotinine result at screening
- •10. Demonstrated ability to properly use the Tempo® Inhaler
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Contraindication to dihydroergotamine mesylate (DHE)
- •2. Use of any excluded concomitant medications within the 10 days prior to Visit 1
- •3. History of hemiplegic or basilar migraine
- •4. Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial
- •5. Diagnosis of cancer (other than a non-invasive skin cancer) within the 5 years prior to Visit 1
- •6. Major surgery, vascular surgery or sepsis during the 6 months prior to Visit 1 (major surgery is defined as any surgery requiring general anesthesia and hospitalization for = 2 days post operatively)
- •7. History of unstable psychiatric illness requiring medication or hospitalization in the 12 months leading up to Visit 1
- •8. Subjects who have known allergy or sensitivity to study drugs or their formulations
- •9. Women who are pregnant, breast feeding or plan a pregnancy during this trial
- •10. Clinically significant liver (any/all of SGPT > 150U/L; SGOT > 130 U/L or LDH > 750 U/L) or kidney disease (serum creatinine > 4.0 mg/dL)
- •11. History of chronic pulmonary disease
- •12. History of coronary artery disease (CAD), coronary vasospasm (including Prinzmetal’s angina), aortic aneurysm, peripheral vascular disease or other ischemic diseases (e.g., ischemic bowel syndrome or Raynaud’s syndrome)
- •13. The following CAD risk factor:
- •Hypertension (systolic BP > 140 or diastolic BP > 90)
- •Or any 2 of the following 4 CAD risk factors:
- •Receiving anti hypertensive medication for the treatment of hypertension.
- •Hyperlipidemia – (LDL) > 159 mg/dL and/or (HDL) < 40 mg/dL (or on prescribed anti
- •cholesterol treatment)
- •Family history of premature coronary artery disease (CAD) (< 55 years of age in male first
- •degree relatives or < 65 years of age in female first degree relatives)
- •Diabetes mellitus
- •14. History of cerebral vascular accident (CVA), transient ischemic attacks (TIA), or seizures
- •15. History of concurrent illness that requires hospitalization within the 30 days prior to Visit 1
- •16. History of bronchospasm with any inhaled medication or other inhaled substance, such as CFC or HFA propellants
- •17. Subjects who have received other diagnostic or research radiation exposure in the last 12 months, with the exception of routine dental x-rays
- •18. Any condition that, in the opinion of the Investigator, would make the subject unsuitable for study participation and completion, including but not limited to:
- •Any reason to believe that compliance with the study requirements and completion of evaluations required for this study will not be possible
- •Any language barrier that, in the opinion of the Investigator, would preclude
- •communication and compliance with the study requirements
- •History or current abuse or dependence on alcohol or drugs that would interfere with adherence to study requirements
- •Any clinically relevant abnormal findings in the physical exam, vital signs or laboratory tests that, in the opinion of the Investigator, may put the subject at risk
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