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Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector (AAS)

Primary Purpose

Seizures

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Midazolam
Sponsored by
U.S. Army Office of the Surgeon General
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures focused on measuring Nerve agent, Midazolam, Seizures, Severe recurrent convulsive seizures induced by nerve agent exposure

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Generally health adult
  • Physically fit
  • Body Mass Index of >/- 19 and </- 26 and a body weight of 55 to 85 Kg
  • Have adequate venous access and sufficient upper leg muscle tissue
  • Have all specified laboratory values
  • Have a negative assay for HIV-1, HIV-2, HbsAg
  • If femal is of child bearing potential, she must not be pregnant or breast feeding, nor plan to become pregnant for th eduration of the study. She must have a negative blood serum pregnancy test within 21 days of treatment, and a negative urine pregnancy test prior to dosing.
  • Females of childbearing potential will use adequate contraception.
  • Willing to refrain from donating blood for 8 weeks after compeletion of the study.

Exclusion Criteria:

  • Participated in a pharmacokinetic study or any clinical study currently or within the last 30 days or donated >480mL of blood within the last 8 weeks.
  • History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestingal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease that could potentially impact the safety of the subject or metabolism of the drug.
  • Be taking any medications to ttreat a chronic medical condition
  • Have ongoing drug abuse/dependence (including alcohol); or history of or treatment for alcohol or drug abuse
  • History of allergic or untoward reaction to any benzodiazepine or any psychotropic agent
  • Currently suffering frm acute or chronic pulmonary disease
  • Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with objectives of the study or the safety of the subject.
  • Pregnant or nursing
  • History of glaucoma
  • Positive urine test for drug abuse
  • Have an active malignancy or history of metastatic or hematologic malignancy with the exception of melanoma in situ or basal or squamous cell carcnoma of the skin Subjects with positive tests for hepatitis B, hepatitis C, syphilis, HIV-1 or HIV-2
  • Subjects whoe ECG reveals a PR interval >/- 190 msec
  • Subjects should refrain from taking any OTC preparations, herbal remedies, and/or nutritional supplement taken within 7 days prior to study drug drug administration.
  • Subjects not using medically recognized means of birth control
  • Subjects with a prior history of seizures or related conditions

Sites / Locations

  • BASi Baltimore Clinical Research Unit

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 20, 2007
Last Updated
September 21, 2007
Sponsor
U.S. Army Office of the Surgeon General
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1. Study Identification

Unique Protocol Identification Number
NCT00534378
Brief Title
Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector
Acronym
AAS
Official Title
Phase I, Open-Label, Single-Center Study to Evaluate the Safety and Dose Linearity of Intramuscular Administration of Midazolam Using
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
U.S. Army Office of the Surgeon General

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose of the study is to determine midazolam's safety and dose-linearity when delivered intramuscularly via an autoinjector. The proposed initial treatment dosage for seizures induced by exposure to nerve agents.
Detailed Description
The investigational drug product being evaluated in this study is the Midazolam Autoinjector. This system is composed of an autoinjector filled with the drug product midazolam EP. The study drug is administered IM into the anterior thigh using the preloaded autoinjector. This method of administration was selected as it is the method that will be used in later clinical trials and for the marketed product. The autoinjectors were preloaded with midazolam 5 mg or 10 mg with a total volume of 1 or 2 mL. Healthy subjects are assigned to one of six target dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
Nerve agent, Midazolam, Seizures, Severe recurrent convulsive seizures induced by nerve agent exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
The study drug was administered IM into the anterior thigh using the preloaded autoinjector. The autoinjectors were preloaded with midazolam 5 mg or 10 mg with a total volume of 1 or 2 mL. Healthy subjects were assigned to one of six target dosage groups (0.10, 0.18, 0.25, 0.33, 0.40, 0.49 mg/kg) and, based on their weight, received the necessary combination of fixed 5 or 10 mg doses to provide the assigned target dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Generally health adult Physically fit Body Mass Index of >/- 19 and </- 26 and a body weight of 55 to 85 Kg Have adequate venous access and sufficient upper leg muscle tissue Have all specified laboratory values Have a negative assay for HIV-1, HIV-2, HbsAg If femal is of child bearing potential, she must not be pregnant or breast feeding, nor plan to become pregnant for th eduration of the study. She must have a negative blood serum pregnancy test within 21 days of treatment, and a negative urine pregnancy test prior to dosing. Females of childbearing potential will use adequate contraception. Willing to refrain from donating blood for 8 weeks after compeletion of the study. Exclusion Criteria: Participated in a pharmacokinetic study or any clinical study currently or within the last 30 days or donated >480mL of blood within the last 8 weeks. History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestingal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease that could potentially impact the safety of the subject or metabolism of the drug. Be taking any medications to ttreat a chronic medical condition Have ongoing drug abuse/dependence (including alcohol); or history of or treatment for alcohol or drug abuse History of allergic or untoward reaction to any benzodiazepine or any psychotropic agent Currently suffering frm acute or chronic pulmonary disease Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-study screening assessment that could interfere with objectives of the study or the safety of the subject. Pregnant or nursing History of glaucoma Positive urine test for drug abuse Have an active malignancy or history of metastatic or hematologic malignancy with the exception of melanoma in situ or basal or squamous cell carcnoma of the skin Subjects with positive tests for hepatitis B, hepatitis C, syphilis, HIV-1 or HIV-2 Subjects whoe ECG reveals a PR interval >/- 190 msec Subjects should refrain from taking any OTC preparations, herbal remedies, and/or nutritional supplement taken within 7 days prior to study drug drug administration. Subjects not using medically recognized means of birth control Subjects with a prior history of seizures or related conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Holohan, MD
Organizational Affiliation
Bioanalytical Systems, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
BASi Baltimore Clinical Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector

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