Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2017
INTERVENTION: Arm 1: Single dose 1.45 mg Dihydroergotamine Mesylate (DHE), administered by I123 Precision Olfactory Delivery (POD TM) device nasal spray (INP104). The 'wash out' period between each treatment will be 7days. CONDITION: Migraine headache PRIMARY OUTCOME: 1. DHE pharmacokinetics (PK) after a single dose of INP104, D.H.E.45 for Injection (IV) and Migranal Nasal Spray including plasma Cmax, Tmax, AUC0‐t, kel, T1/2, AUC0‐inf, and CL/F (CL for IV administration). SECONDARY OUTCOME: 1. Safety and tolerability, including the assessment of physical examinations, electrocardiograms (ECGs), vital signs, clinical laboratory results, and adverse events . 2. 8’‐OH‐DHE pharmacokinetics after a single dose of INP104, D.H.E. 45 for Injection (IV) and Migranal Nasal Spray including plasma Cmax, Tmax, AUC0‐t, kel, T1/2, AUC0‐inf, and CL/F (CL for IV administration). 3. Comparison of the subject acceptability of INP104 to that of DHE for Injection (IV) and Migranal Nasal Spray by completion of a sponsor designed questionnaire specifically for this study by all subjects INCLUSION CRITERIA: 1. Adult male and females, 18 to 55 years of age (inclusive) at the time of screening. 2. Subjects must be in good general health, with no significant medical history (including migraine), have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of investigational product. 3. Subjects must have a Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive. 4. Subjects must have clinical laboratory values within normal range as specified by the testing laboratory, or assessed as not clinically significant by the Principal Investigator. 5. Negative urine drug screen/alcohol breath test at screening. 6. Subjects who are willing to refrain from smoking for the duration of the study. 7. Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 30 days after the last dose of investigational product. A female o
Epistemonikos ID: 48b3834d3d610a70cad952b77be32cfdaf05e358
First added on: Aug 23, 2024