Phase 1, Open-Label, Comparison Study to Evaluate the Safety and Pharmacokinetics of a Single Intramuscular Administration of 10 mg Midazolam Using an Auto-Injector vs Marketed Midazolam Vials in Healthy Adults.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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-∞)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Can understand and provide signed informed consent
- •Is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ECG are within normal range
- •Has a willingness to comply and be available for all protocol procedures
- •Is between age 18 and 55 years, inclusive on the day of injection
- •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
- •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®)
- •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
- •Has a body mass index (BMI) ≥18.0 and ≤26.0 kg/m2 at screening
- •Has a negative urine drug screen
- •Has a negative breathalyzer test
- •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
- •Subject agrees to not take any vitamins or supplements 48 hours prior to dosing
- •Is available for follow-up for the duration of the study
Exclusion Criteria
- •Received treatment with another investigational drug within 28 days of initial dosing
- •Has a current or history of drug and /or alcohol abuse
- •Is pregnant or breastfeeding woman
- •Has hypersensitivity or allergy to midazolam
- •Has hypersensitivity or allergy to benzodiazepines
- •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
- •Tests positive for HIV-1, HIV-2, HbsAg, hepatitis C antibody, or syphilis
- •Has had a blood donation in the 8 weeks prior to the study period start date
Arms & Interventions
Midazolam Injection
Midazolam injection, 10 mg
Intervention: Midazolam (Combination Product)
Seizalam™
Seizalam, 10 mg
Intervention: Seizalam (Drug)
Outcomes
Primary Outcomes
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-∞)
Time Frame: 28 days
number of participants with vital signs changes resulting in a serious adverse event
Time Frame: 28 days
number of participants with local injection site changes
Time Frame: 28 days
number of participants with systemic changes in physical exam
Time Frame: 28 days
number of participants with ECG changes resulting in a serious adverse event
Time Frame: 28 days
time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection
Time Frame: 28 days
The elimination rate constant (ke) will be estimated
Time Frame: 28 days
number of participants with laboratory changes resulting in a serious adverse event
Time Frame: 28 days
Secondary Outcomes
- Relative bioavailability will be obtained by analysis of AUC0-∞(28 days)
- Relative bioavailability will be obtained by analysis of Cmax(28 days)
- Relative bioavailability will be obtained by analysis of AUC0-last(28 days)