HealthyPhase 1NCT00620620
Staccato Zaleplon Single Dose Pharmacokinetics
A Phase 1 study testing Inhaled Zaleplon 0.5 mg, Inhaled Zaleplon 1 mg and Inhaled Zaleplon 2 mg in people with Healthy, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers 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?
- Inhaled Zaleplon 0.5 mg, Inhaled Zaleplon 1 mg and Inhaled Zaleplon 2 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2008
- 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 who are in good general health
Who cannot join
- Subjects with a history of allergy or intolerance to zaleplon. 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Evansville, Indiana, 47714
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato® Zaleplon for Inhalation in Healthy Volunteers
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers
- Conditions
- Healthy
- Being tested
- Inhaled placebo, Inhaled Zaleplon 0.5 mg, Inhaled Zaleplon 1 mg, Inhaled Zaleplon 2 mg, Inhaled Zaleplon 4 mg
- Keywords
- Healthy adult volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled placeboDrug
Also called Staccato Placebo
Inhaled Staccato Placebo
Inhaled Zaleplon 0.5 mgDrug
Also called Staccato Zaleplon 0.5 mg
Inhaled Staccato Zaleplon 0.5 mg
Inhaled Zaleplon 1 mgDrug
Also called Staccato Zaleplon 1 mg
Inhaled Staccato Zaleplon 1 mg
Inhaled Zaleplon 2 mgDrug
Also called Staccato Zaleplon 2 mg
Inhaled Staccato Zaleplon 2 mg
Inhaled Zaleplon 4 mgDrug
Also called Staccato Zaleplon 4 mg
Inhaled Staccato Zaleplon 4 mg
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Staccato Placebo Receives: Drug: Inhaled placebo |
| Inhaled Zaleplon 0.5 mg | Experimental | Staccato Zaleplon 0.5 mg Receives: Drug: Inhaled Zaleplon 0.5 mg |
| Inhaled Zaleplon 1 mg | Experimental | Staccato Zaleplon 1 mg Receives: Drug: Inhaled Zaleplon 1 mg |
| Inhaled Zaleplon 2 mg | Experimental | Staccato Zaleplon 2 mg Receives: Drug: Inhaled Zaleplon 2 mg |
| Inhaled Zaleplon 4 mg | Experimental | Staccato Zaleplon 4 mg Receives: Drug: Inhaled Zaleplon 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;
Measured: Single dose
Secondary outcomes (1)
Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses
Measured: single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel A Spyker, MD, Study director, Alexza Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620620
- Sponsor's protocol ID
- AMDC-007-101
- Other IDs
- 17 December 2007
- Status last verified
- Jul 2013
- First submitted
- 7 Feb 2008
- 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
Publications
Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886.
PubMed 23436259
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 Staccato® Zaleplon for Inhalation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00620620
- Acronym / sponsor ID
- AMDC-007-101
- Conditions
- Healthy
- Keywords
- Healthy adult volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Feb 2008 (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.
The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Inhaled Placebo | Placebo comparator | Drug: Inhaled placeboStaccato Placebo |
| Inhaled Zaleplon 0.5 mg | Experimental | Drug: Inhaled Zaleplon 0.5 mgStaccato Zaleplon 0.5 mg |
| Inhaled Zaleplon 1 mg | Experimental | Drug: Inhaled Zaleplon 1 mgStaccato Zaleplon 1 mg |
| Inhaled Zaleplon 2 mg | Experimental | Drug: Inhaled Zaleplon 2 mgStaccato Zaleplon 2 mg |
| Inhaled Zaleplon 4 mg | Experimental | Drug: Inhaled Zaleplon 4 mgStaccato Zaleplon 4 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health
Key exclusion criteria (1 listed)
- Subjects with a history of allergy or intolerance to zaleplon. 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.
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 |
|---|---|---|
| Inhaled placeboAlso: Staccato PlaceboInhaled Staccato Placebo | Drug | Inhaled Placebo |
| Inhaled Zaleplon 0.5 mgAlso: Staccato Zaleplon 0.5 mgInhaled Staccato Zaleplon 0.5 mg | Drug | Inhaled Zaleplon 0.5 mg |
| Inhaled Zaleplon 1 mgAlso: Staccato Zaleplon 1 mgInhaled Staccato Zaleplon 1 mg | Drug | Inhaled Zaleplon 1 mg |
| Inhaled Zaleplon 2 mgAlso: Staccato Zaleplon 2 mgInhaled Staccato Zaleplon 2 mg | Drug | Inhaled Zaleplon 2 mg |
| Inhaled Zaleplon 4 mgAlso: Staccato Zaleplon 4 mgInhaled Staccato Zaleplon 4 mg | Drug | Inhaled Zaleplon 4 mg |
Primary outcome
Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;
Time frame: Single dose
1 secondary outcome
Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses
Time frame: single dose
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.
- Background: PubMed 23436259Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886.
- 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.
Daniel A Spyker, MD study director
Alexza Pharmaceuticals, Inc.
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 Inhaled Zaleplon 0.5 mg, Inhaled Zaleplon 1 mg and Inhaled Zaleplon 2 mg in people with Healthy, run by Alexza Pharmaceuticals, Inc. 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 1 inclusion and 1 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.
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. Some participants in this study may receive a placebo. 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?
Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; (time frame: Single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00620620, which also lists 1 linked publication.
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.