Study of Midazolam in Healthy Adults

Status Epilepticus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679623
• Other study ID #: RLM-559-01
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2021
• Est. completion date: September 17, 2021

Study information

• Verified date: March 2022
• Source: Rafa Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 17, 2021
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Status Epilepticus

Intervention

Combination Product:
• Midazolam
Midazolam Injection, 10mg

Drug:
• Seizalam
Seizalam, 10 mg

Locations

Country	Name	City	State
United States	Wake Research	Raleigh	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Rafa Laboratories	Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical, Ology Bioservices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with local injection site changes		28 days
Primary	number of participants with systemic changes in physical exam		28 days
Primary	number of participants with vital signs changes resulting in a serious adverse event		28 days
Primary	number of participants with ECG changes resulting in a serious adverse event		28 days
Primary	number of participants with laboratory changes resulting in a serious adverse event		28 days
Primary	time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection		28 days
Primary	The elimination rate constant (ke) will be estimated		28 days
Primary	The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-8)		28 days
Secondary	Relative bioavailability will be obtained by analysis of Cmax		28 days
Secondary	Relative bioavailability will be obtained by analysis of AUC0-last		28 days
Secondary	Relative bioavailability will be obtained by analysis of AUC0-8		28 days