EpilepsyPhase 1NCT01364558
A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers
A Phase 1 study testing Diazepam in people with Epilepsy, run by University of Minnesota at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Diazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prism Clinical Research Unit
Saint Paul, Minnesota, 55114
About this study
Official title: 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",
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
Read the 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
- Conditions
- Epilepsy
- Being tested
- Diazepam
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
Also called Brand names include: Valium, Diastat
Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.
DiazepamDrug
Also called Valium Injectable, Diastat Rectal Gel
IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.
| Study group | Role | What they receive |
|---|---|---|
| Diazepam Nasal Spray Suspension | Experimental | Diazepam Nasal Suspension - 10 mg Receives: Drug: Diazepam |
| Diazepam Nasal Spray Solution | Experimental | Diazepam Nasal Spray Solution - 10 mg Receives: Drug: Diazepam |
| Diazepam injection | Active comparator | Diazepam injection IV - 5 mg Receives: Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Neurelis, Inc.
- Responsible party
- Sponsor
- Investigators
- James Cloyd, Pharm D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364558
- Sponsor's protocol ID
- 1012M93599
- Status last verified
- Oct 2019
- First submitted
- 20 May 2011
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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",
- ClinicalTrials.gov ID
- NCT01364558
- Acronym / sponsor ID
- 1012M93599
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Neurelis, Inc.
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Posted 20 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diazepam Nasal Spray Suspension | Experimental | Drug: DiazepamDiazepam Nasal Suspension - 10 mg |
| Diazepam Nasal Spray Solution | Experimental | Drug: DiazepamDiazepam Nasal Spray Solution - 10 mg |
| Diazepam injection | Active comparator | Drug: DiazepamDiazepam injection IV - 5 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiazepamAlso: Brand names include: Valium, DiastatDiazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose. | Drug | Diazepam Nasal Spray Solution, Diazepam Nasal Spray Suspension |
| DiazepamAlso: Valium Injectable, Diastat Rectal GelIV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses. | Drug | Diazepam Nasal Spray Solution, Diazepam Nasal Spray Suspension, Diazepam injection |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cloyd, Pharm D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diazepam in people with Epilepsy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.