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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
Sponsored by
Rafa Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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

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

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
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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
No

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
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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