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.

Rafa Laboratories1 site in 1 country40 target enrollmentJune 9, 2021

ConditionsStatus Epilepticus

InterventionsMidazolam Seizalam

DrugsSeizalam

Overview

Phase: Phase 1
Intervention: Midazolam
Conditions: Status Epilepticus
Sponsor: Rafa Laboratories
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-∞)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 9, 2021

End Date

September 17, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Rafa Laboratories

Responsible Party

Sponsor

Eligibility Criteria

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

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