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

NCT01364558 | Completed Phase 1 Results DMC

• 1 other identifier: 1012M93599
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations.

  To calculate bioavailability we used the following formula: Area Under the Curve (Intranasal Spray)\*100/Area Under the Curve (Intravenous Injection)

  2 days

Study Arms (3)

Diazepam Nasal Spray Suspension

EXPERIMENTAL

Diazepam Nasal Suspension - 10 mg

Drug: Diazepam

Diazepam Nasal Spray Solution

EXPERIMENTAL

Diazepam Nasal Spray Solution - 10 mg

Drug: Diazepam

Diazepam injection

ACTIVE COMPARATOR

Diazepam injection IV - 5 mg

Drug: Diazepam

Interventions

Diazepam DRUG

Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.

Also known as: Brand names include: Valium, Diastat

Diazepam Nasal Spray Solution; Diazepam Nasal Spray Suspension

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects between the ages of 18 and 45 years (inclusive).
• Written informed consent to participate in the study.
• Body mass index (BMI) between 19 and 30 kg/m², inclusive.
• 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.
• No clinically significant abnormal findings in the medical history, on the physical examination, electrocardiogram (ECG), or clinical laboratory results during Screening.
• 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.

You may not qualify if:

• 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.
• A history of allergic or adverse responses to diazepam or any comparable or similar product.
• 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.
• Subjects who donated blood or plasma within 30 days of the first dose of study drug.
• 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.
• Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
• 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.
• 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.
• 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.
• Smoking or use of tobacco products within six (6) months prior to the first dose of study drug or during the study.
• Female subjects who are trying to conceive, are pregnant, or are lactating.
• Positive serum pregnancy test at Screening or urine pregnancy test prior to each administration of study drug for all women, regardless of childbearing potential.
• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Neurelis, Inc.: collaborator

Study Sites (1)

Prism Clinical Research Unit

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Diazepam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. James Cloyd, Director for Center for Orphan drug research
• Organization: University of Minnesota

cloyd001@umn.edu

612-624-4609

Study Officials

• James Cloyd, Pharm D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: June 2, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 1, 2019
• Results First Posted: June 20, 2014

Record last verified: 2019-10

Locations

US (1)