Study of Midazolam in Healthy Adults

NCT ID: NCT04679623

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2021-09-17

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.

Conditions

Status Epilepticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midazolam Injection

Midazolam injection, 10 mg

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: COMBINATION_PRODUCT

Midazolam Injection, 10mg

Seizalam™

Seizalam, 10 mg

Group Type: ACTIVE_COMPARATOR

Seizalam

Intervention Type: DRUG

Seizalam, 10 mg

Interventions

Midazolam

Midazolam Injection, 10mg

Intervention Type: COMBINATION_PRODUCT

Seizalam

Seizalam, 10 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: collaborator

Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical

UNKNOWN

Sponsor Role: collaborator

Rafa Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wake Research

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

RLM-559-01

Identifier Type: -

Identifier Source: org_study_id