Introduction of conscious sedation epilepsy procedural sedation
Conditions
Interventions
Midazolam nasal spray, injection and placebo.
Sponsors
Medir B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18-55 years (both inclusive). 2. Females with reproductive potential should agree to remain abstinent or use (and have her partner use) acceptable methods of birth control throughout the study. 3. Voluntary provision of written informed consent prior to any study procedure, indicative of understanding the purpose of the study and willing to participate in the study and comply with the study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1. Subject is unhealthy according to medical history, physical examination, ECG, blood pressure and heart rate, and laboratory profile of blood and urine. A volunteer with a clinical abnormality may be included only if the investigator or his designee considers that the abnormality will not introduce additional risk factor for the subject's health, or interfere with the study objectives. 2. Presence or history of clinical significant psychiatric diseases, as judged by the investigator. 3. Any clinically relevant acute or chronic diseases which according to the investigator could interfere with the subject*s safety during the trial, or expose them to undue risk, or which could interfere with the study objectives. 4. Presence or history of clinical significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system or presence of history of clinical significant immunological, endocrine, metabolic diseases, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, as judged by the investigator. 5. Presence or history of clinically significant allergy or known hypersensitivity to any component of the investigational product. 6. Clinically significant upper respiratory infection, common cold or flu -like symptoms and/or rhinitis, as judged by the investigator. 7. Presence or history of clinically significant nasal abnormalities (e.g. polyps or other physical abnormalities), as judged by the investigator. 8. Recent ( 33 kg/m2. 11. Has positive serology for HIV, hepatitis B (surface antigen), and/or hepatitis C antibodies. 12. Has planned medical treatments (including dental care) between screening and follow-up visit. 13. Use of prescribed medication or over-the-counter (OTC) medication within two weeks prior to dosing, except for paracetamol (up to 1.5 g per day). 14. Enrolment in any investigational study or intake of an investigational drug within 3 months prior to the start of the study or more than 4 times a year. 15. Current regular user of any illicit drugs or history of drug or alcohol abuse and history of any drug use taken intransally (e.g. cocaine). Subjects who have a positive drug screen, or have a positive alcohol breath test at screening will be excluded. 16. Donation of blood/plasma outside limits of Sanquin Blood Supply Foundation guidelines. 17. Unlikely to co-operate in the study, and/or has poor compliance anticipated by the investigator. Or not consistently reachable in case of emergency. 18. Daily consumption of xanthine-containing products more than 8 units. Unwilling or unable to refrain from consumption of xanthine-containing foods or drinks from 1 days prior to admission and during the stay in the research unit. One caffeine unit is contained in the following items: one cup of coffee, two cans of cola, one glass of tea, * cup of energy drink (e.g. Red Bull) or three chocolate bars. 19. Unwilling or unable to refrain from intensive physical exercise from screening until the follow-up visit. 20. Unwilling or unable to refrain from products containing alcohol from 1 days before admission and during the stay in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: • Peak Saccadic Velocity • Visual Analogue Scale (Bond and Lader) for sedation • Observer*s Assessment of Alertness/Sedation Scale • Simple Reaction Time Task Pharmacokinetics: • AUC 0-t: The area under the plasma concentration time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method. • AUC0-*: The area under the plasma concentration time curve from time 0 to infinity. • AUCextrap: Percent of the AUC located from the last quantifiable plasma concentration to infinity. • CL: Total systemic clearance. • V: Volume of distribution. • F: Bioavailability. • Cmax: Maximum measured plasma concentration over the time span specified. • Tmax: Time of the maximum measured plasma concentration. • t*: The apparent first-order terminal elimination half-life. • kel: apparent first-order terminal elimination rate constant. Safety and tolerability: • Adverse events, vital signs, ECG, blood hematology and chemistry, pulse oxymetry and ENT-examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed