Status Epilepticus
Conditions
Brief summary
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.
Interventions
COMBINATION_PRODUCTMidazolam
Midazolam Injection, 10mg
DRUGSeizalam
Seizalam, 10 mg
Sponsors
Alachua Government Services, Inc.
Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical
Rafa Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Can understand and provide signed informed consent 2. Is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ECG are within normal range 3. Has a willingness to comply and be available for all protocol procedures 4. Is between age 18 and 55 years, inclusive on the day of injection 5. If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to injection Note: A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful Essure placement with documented confirmation test at least 3 months after the procedure 6. If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception up to 1 month after the end of study visit Note: Acceptable contraception methods are restricted to effective devices (approved oral contraceptives, Intrauterine Contraceptive Devices, NuvaRing®) 7. If the subject is male, he agrees to practice abstinence from sexual intercourse with women or use acceptable contraception up to 1 month after the end of study visit 8. Has a body mass index (BMI) ≥18.0 and ≤26.0 kg/m2 at screening 9. Has a negative urine drug screen 10. Has a negative breathalyzer test 11. Subject is not taking any medications or St. John's wort and agrees to avoid grapefruit juice and alcohol until study completion on Day 28 12. Subject agrees to not take any vitamins or supplements 48 hours prior to dosing 13. Is available for follow-up for the duration of the study
Exclusion criteria
1. Received treatment with another investigational drug within 28 days of initial dosing 2. Has a current or history of drug and /or alcohol abuse 3. Is pregnant or breastfeeding woman 4. Has hypersensitivity or allergy to midazolam 5. Has hypersensitivity or allergy to benzodiazepines 6. Has a history of cardiovascular, pulmonary, neurological, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or psychiatric disease or any other reason, in the opinion of the investigator, that the patient should not participate 7. Tests positive for HIV-1, HIV-2, HbsAg, hepatitis C antibody, or syphilis 8. Has had a blood donation in the 8 weeks prior to the study period start date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-∞) | 28 days |
| number of participants with laboratory changes resulting in a serious adverse event | 28 days |
| time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection | 28 days |
| The elimination rate constant (ke) will be estimated | 28 days |
| number of participants with local injection site changes | 28 days |
| number of participants with systemic changes in physical exam | 28 days |
| number of participants with vital signs changes resulting in a serious adverse event | 28 days |
| number of participants with ECG changes resulting in a serious adverse event | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Relative bioavailability will be obtained by analysis of AUC0-last | 28 days |
| Relative bioavailability will be obtained by analysis of AUC0-∞ | 28 days |
| Relative bioavailability will be obtained by analysis of Cmax | 28 days |
Countries
United States
Outcome results
None listed