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
- Conditions
- migraineMedDRA version: 12.0Level: LLTClassification code 10027599Term: Migraine
- Registration Number
- EUCTR2009-016732-12-GB
- Lead Sponsor
- MAP Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method