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

September 21, 2007 updated by: U.S. Army Office of the Surgeon General

Phase I, Open-Label, Single-Center Study to Evaluate the Safety and Dose Linearity of Intramuscular Administration of Midazolam Using

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • BASi Baltimore Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Drug: Midazolam
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Office of the Surgeon General

Investigators

  • Principal Investigator: Thomas Holohan, MD, Bioanalytical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 21, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 24, 2007

Last Update Submitted That Met QC Criteria

September 21, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11903 (DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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