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Study of Midazolam in Healthy Adults

Primary Purpose

Status Epilepticus

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Midazolam

Seizalam

About this trial

This is an interventional treatment trial for Status Epilepticus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wake Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Midazolam Injection

Seizalam™

Arm Description

Midazolam injection, 10 mg

Seizalam, 10 mg

Outcomes

Primary Outcome Measures

number of participants with local injection site changes

number of participants with systemic changes in physical exam

number of participants with vital signs changes resulting in a serious adverse event

number of participants with ECG changes resulting in a serious adverse event

number of participants with laboratory changes resulting in a serious adverse event

time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection

The elimination rate constant (ke) will be estimated

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-∞)

Secondary Outcome Measures

Relative bioavailability will be obtained by analysis of Cmax

Relative bioavailability will be obtained by analysis of AUC0-last

Relative bioavailability will be obtained by analysis of AUC0-∞

Full Information

NCT ID

NCT04679623

First Posted

December 15, 2020

Last Updated

March 2, 2022

Sponsor

Rafa Laboratories

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04679623

Brief Title

Study of Midazolam in Healthy Adults

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

June 9, 2021 (Actual)

Primary Completion Date

September 17, 2021 (Actual)

Study Completion Date

September 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rafa Laboratories

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Status Epilepticus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Midazolam Injection

Arm Type

Experimental

Arm Description

Midazolam injection, 10 mg

Arm Title

Seizalam™

Arm Type

Active Comparator

Arm Description

Seizalam, 10 mg

Intervention Type

Combination Product

Intervention Name(s)

Midazolam

Intervention Description

Midazolam Injection, 10mg

Intervention Type

Drug

Intervention Name(s)

Seizalam

Intervention Description

Seizalam, 10 mg

Primary Outcome Measure Information:

Title

number of participants with local injection site changes

Time Frame

28 days

Title

number of participants with systemic changes in physical exam

Time Frame

28 days

Title

number of participants with vital signs changes resulting in a serious adverse event

Time Frame

28 days

Title

number of participants with ECG changes resulting in a serious adverse event

Time Frame

28 days

Title

number of participants with laboratory changes resulting in a serious adverse event

Time Frame

28 days

Title

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

Title

The elimination rate constant (ke) will be estimated

Time Frame

28 days

Title

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

Secondary Outcome Measure Information:

Title

Relative bioavailability will be obtained by analysis of Cmax

Time Frame

28 days

Title

Relative bioavailability will be obtained by analysis of AUC0-last

Time Frame

28 days

Title

Relative bioavailability will be obtained by analysis of AUC0-∞

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

Wake Research

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

12. IPD Sharing Statement

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Study of Midazolam in Healthy Adults

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