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A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers

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: NCT01364558
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : June 20, 2014
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Neurelis, Inc.
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE June 2, 2011
Results First Submitted Date  ICMJE July 20, 2012
Results First Posted Date  ICMJE June 20, 2014
Last Update Posted Date November 1, 2019
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations. [ Time Frame: 2 days ]
To calculate bioavailability we used the following formula: Area Under the Curve (Intranasal Spray)*100/Area Under the Curve (Intravenous Injection)
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
Comparison of the absolute bioavailability of two intranasal diazepam formulations [ Time Frame: 10 months ]
Subjects will be given either the study drug or a pplacebo over a period of 2 days. This will measure the effectaness of the nasal spray vs a pill.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
Official Title  ICMJE A Three-Period, Three-Treatment, Six-Sequence Randomized Crossover Study of the Bioavailability and Pharmacokinetics of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers",
Brief Summary The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration
Detailed Description

Diazepam is a medication that is used for the treatment of seizures. It was approved by the Food and Drug Administration (FDA) for use in the United States and is currently sold as Valium® tablets, Diazepam Injection and Diastat® rectal gel.

This study will evaluate two intranasal (nasal spray) formulations of diazepam which will be supplied by Neurelis, Inc. The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration. "Bioavailability" is a measure of how much drug is absorbed and present in the blood. "Pharmacokinetics" means to study the way a drug enters and leaves the blood and tissues over time

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Diazepam
    Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.
    Other Name: Brand names include: Valium, Diastat
  • Drug: Diazepam
    IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.
    Other Name: Valium Injectable, Diastat Rectal Gel
Study Arms  ICMJE
  • Experimental: Diazepam Nasal Spray Suspension
    Diazepam Nasal Suspension - 10 mg
    Interventions:
    • Drug: Diazepam
    • Drug: Diazepam
  • Experimental: Diazepam Nasal Spray Solution
    Diazepam Nasal Spray Solution - 10 mg
    Interventions:
    • Drug: Diazepam
    • Drug: Diazepam
  • Active Comparator: Diazepam injection
    Diazepam injection IV - 5 mg
    Intervention: Drug: Diazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2011)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female subjects between the ages of 18 and 45 years (inclusive).
  2. Written informed consent to participate in the study.
  3. Body mass index (BMI) between 19 and 30 kg/m², inclusive.
  4. Female subjects of childbearing potential, defined as not surgically sterile or at least two years (2) postmenopausal, must agree to use one of the following forms of contraception from three (3) months prior through 12 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (six months minimum). Subjects must have used the same method for at least three (3) months prior to starting the study.
  5. No clinically significant abnormal findings in the medical history, on the physical examination, electrocardiogram (ECG), or clinical laboratory results during Screening.
  6. Subjects must agree to return to the study site for all study visits, including the three (3) confinement periods, and must be willing to comply with all required study procedures.

Exclusion Criteria:

  1. A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non seasonal allergies, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration, or any other condition which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
  2. A history of allergic or adverse responses to diazepam or any comparable or similar product.
  3. Subjects who (for whatever reason) have been on an abnormal diet (such as one that severely restricts specific basic food groups [e.g., ketogenic diet], limits calories [e.g., fast], and/or requires the use of daily supplements as a substitute for the foods typically eaten at mealtimes), during the four (4) weeks preceding the study.
  4. Subjects who donated blood or plasma within 30 days of the first dose of study drug.
  5. Participation in a clinical trial within 30 days prior to the first dose of study drug. Participation in an observational (non interventional) study is not excluded as long as there are no scheduling conflicts with this study.
  6. Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
  7. Use of any over the counter (OTC) medication, including vitamins, within seven (7) days prior to the first dose of the study drug or during the study, unless approved by the Principal Investigator.
  8. Use of any prescription medication, including benzodiazepines, within 14 days prior to the first dose of study drug or during the study, with the exception of hormonal contraceptives for women of childbearing potential, unless approved by the Principal Investigator.
  9. Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study drug or during the study.
  10. Smoking or use of tobacco products within six (6) months prior to the first dose of study drug or during the study.
  11. Female subjects who are trying to conceive, are pregnant, or are lactating.
  12. Positive serum pregnancy test at Screening or urine pregnancy test prior to each administration of study drug for all women, regardless of childbearing potential.
  13. Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol, drugs of abuse, or cotinine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01364558
Other Study ID Numbers  ICMJE 1012M93599
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Neurelis, Inc.
Investigators  ICMJE
Principal Investigator: James Cloyd, Pharm D. University of Minnesota
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP