HealthyPhase 1NCT00444522
Staccato Alprazolam Single Dose PK
A Phase 1 study testing Alprazolam thermal aerosol in people with Healthy, run by Alexza Pharmaceuticals, Inc..
Trial summary
We are developing Staccato Alprazolam for the acute treatment of panic attacks associated with panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Alprazolam thermal aerosol
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Aug 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects between the ages of 18 to 55 years, inclusive.
- Subjects with a body mass index (BMI) ≥21 and ≤30.
- Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures.
- Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) and comply with the study schedule and study requirements.
- Subjects who are in good general health as determined by a complete medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, and urinalysis.
Who cannot join
- Subjects who regularly consume large amounts of xanthine-containing substances (ie, more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
- Subjects who have taken prescription or nonprescription medication (with the exception of vitamins and acetaminophen if medically necessary) within 5 days of Visit 2 (Baseline).
- Subjects who have had an acute illness within 5 days of Visit 2 (Baseline).
- Subjects who have received an investigational drug within 30 days (or within 5 half lives investigational drug, if >30 days) prior to Visit 2 (Baseline).
- Subjects who have smoked tobacco within the last year.
- Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4.
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- Subjects with a history of HIV positivity.
- Subjects with a history of allergy or intolerance to benzodiazepines or related drugs (alprazolam, lorazepam, diazepam, etizolam, clonazepam, adinazolam).
- Subjects who test positive for alcohol or have a positive urine drug screen at Visit 1 or Visit 2.
- Subjects who have hypotension (systolic blood pressure ≤90 mmHg, diastolic blood pressure ≤50 mmHg), or hypertension (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).
- Subjects who have a clinically significant ECG abnormality.
- Subjects with a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure (CHF), stroke, transient ischemic attack (TIA), or a neurological disorder.
- Subjects who have a history of pulmonary disease that precludes administration of Staccato Alprazolam (asthma, bronchitis, bronchospasm, emphysema).
- Subjects who have an FEV1 less than 80% of predicted values on spirometry assessments at Visit 1.
- Female subjects who are breastfeeding or have a positive pregnancy test at Visit 1 or Visit 2.
- Female participants of child-bearing potential or within 1 year of menopause, and sexually active are excluded unless they use a medically acceptable and effective birth control method throughout the study and for 1 week following the end of the study. Medically acceptable methods of contraception include abstinence, diaphragm with spermicide, intrauterine device (IUD), condom with foam or spermicide, vaginal spermicidal suppository, surgical sterilization, and progestin implant or injection. Unacceptable methods include: birth control pills, patches, and injections, the rhythm method, withdrawal, condoms alone, or diaphragm alone.
- Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of StaccatoTM Alprazolam for Inhalation in Normal, Healthy Volunteers
We are developing Staccato Alprazolam for the acute treatment of panic attacks associated with panic disorder.
- Conditions
- Healthy
- Being tested
- Alprazolam thermal aerosol
- Keywords
- Panic attacks, Staccato® Alprazolam
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam thermal aerosolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile and dose proportionality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJun 2005
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Randall Stoltz, MD, Principal investigator, West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444522
- Sponsor's protocol ID
- AMDC-002-101
- Status last verified
- Mar 2007
- First submitted
- 5 Mar 2007
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of a Single Dose of StaccatoTM Alprazolam for Inhalation in Normal, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00444522
- Acronym / sponsor ID
- AMDC-002-101
- Conditions
- Healthy
- Keywords
- Panic attacks, Staccato® Alprazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Jun 2005 (actual)
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are developing Staccato Alprazolam for the acute treatment of panic attacks associated with panic disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects between the ages of 18 to 55 years, inclusive.
- Subjects with a body mass index (BMI) ≥21 and ≤30.
- Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures.
- Subjects who are willing and able to be confined to the Clinical Research Unit (CRU) and comply with the study schedule and study requirements.
- Subjects who are in good general health as determined by a complete medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, and urinalysis.
Key exclusion criteria (17 listed)
- Subjects who regularly consume large amounts of xanthine-containing substances (ie, more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day).
- Subjects who have taken prescription or nonprescription medication (with the exception of vitamins and acetaminophen if medically necessary) within 5 days of Visit 2 (Baseline).
- Subjects who have had an acute illness within 5 days of Visit 2 (Baseline).
- Subjects who have received an investigational drug within 30 days (or within 5 half lives investigational drug, if >30 days) prior to Visit 2 (Baseline).
- Subjects who have smoked tobacco within the last year.
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 |
|---|---|---|
| Alprazolam thermal aerosol | Drug | – |
Primary outcome
Pharmacokinetic profile and dose proportionality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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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.
Randall Stoltz, MD principal investigator
West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprazolam thermal aerosol in people with Healthy, run by Alexza Pharmaceuticals, Inc..
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 5 inclusion and 17 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic profile and dose proportionality. 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 14 Mar 2017.