Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector (AAS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00534378 |
Recruitment Status :
Completed
First Posted : September 24, 2007
Last Update Posted : September 24, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Seizures | Drug: Midazolam | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I, Open-Label, Single-Center Study to Evaluate the Safety and Dose Linearity of Intramuscular Administration of Midazolam Using |
Study Start Date : | July 2006 |
Actual Study Completion Date : | December 2006 |
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. |

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Ages Eligible for Study: | 18 Years to 54 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534378
United States, Maryland | |
BASi Baltimore Clinical Research Unit | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Thomas Holohan, MD | Bioanalytical Systems, Inc. |
ClinicalTrials.gov Identifier: | NCT00534378 |
Other Study ID Numbers: |
11903 |
First Posted: | September 24, 2007 Key Record Dates |
Last Update Posted: | September 24, 2007 |
Last Verified: | September 2007 |
Nerve agent Midazolam Seizures Severe recurrent convulsive seizures induced by nerve agent exposure |
Seizures Neurologic Manifestations Nervous System Diseases Midazolam Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents |
Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |