Smoking, CigarettePhase 1NCT00873769
Staccato Loxapine PK in Smokers and Nonsmokers
A Phase 1 study testing Inhaled Loxapine 10 mg in people with Smoking, Cigarette, run by Alexza Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- Inhaled Loxapine 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2009
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
- Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
- Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.
Who cannot join
- Any acute illness in the 5 days,
- Use of a bronchodilator for the treatment of wheezing within 12 months, OR
- Any other disease or condition, by history, physical examination, or laboratory abnormalities that 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, 47710
About this study
Official title: Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.
Read the detailed description
Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.
- Conditions
- Smoking, Cigarette
- Being tested
- Inhaled Loxapine 10 mg
- Keywords
- Staccato Loxapine, pharmacokinetics, smokers, non-smokers
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Loxapine 10 mgDrug
Also called Staccato Loxapine 10 mg
Staccato Loxapine 10 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy smokers | Experimental | Healthy smokers, male and female Receives: Drug: Inhaled Loxapine 10 mg |
| Healthy nonsmokers | Experimental | Healthy nonsmokers, Healthy smokers, male and female Receives: Drug: Inhaled Loxapine 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noncompartmental Pharmacokinetic parameters
Measured: 24 hours
Secondary outcomes (3)
Vital signs
Measured: 24 hours
Treatment emergent adverse events
Measured: 24 hours
Sedation visual analog scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
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 Smoking, CigaretteStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Randall R. Stoltz, MD, Principal investigator, Covance Clincial Research Unit, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873769
- Sponsor's protocol ID
- AMDC-004-106
- Other IDs
- 27 February 2009
- Status last verified
- Jun 2009
- First submitted
- 1 Apr 2009
- Last updated
- 15 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
Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV. Effect of smoking on the pharmacokinetics of inhaled loxapine. Ther Drug Monit. 2014 Oct;36(5):618-23. doi: 10.1097/FTD.0000000000000048.
PubMed 24937085
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
- ClinicalTrials.gov ID
- NCT00873769
- Acronym / sponsor ID
- AMDC-004-106
- Conditions
- Smoking, Cigarette
- Keywords
- Staccato Loxapine, pharmacokinetics, smokers, non-smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alexza Pharmaceuticals, Inc.
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Apr 2009 (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 objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.
Detailed description
Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy smokers | Experimental | Drug: Inhaled Loxapine 10 mgHealthy smokers, male and female |
| Healthy nonsmokers | Experimental | Drug: Inhaled Loxapine 10 mgHealthy nonsmokers, Healthy smokers, male and female |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
- Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
- Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.
Key exclusion criteria (3 listed)
- Any acute illness in the 5 days,
- Use of a bronchodilator for the treatment of wheezing within 12 months, OR
- Any other disease or condition, by history, physical examination, or laboratory abnormalities that 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 Loxapine 10 mgAlso: Staccato Loxapine 10 mgStaccato Loxapine 10 mg, single dose | Drug | Healthy nonsmokers, Healthy smokers |
Primary outcome
Noncompartmental Pharmacokinetic parameters
Time frame: 24 hours
3 secondary outcomes
Vital signs
Time frame: 24 hours
Treatment emergent adverse events
Time frame: 24 hours
Sedation visual analog scale
Time frame: 24 hours
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 15 Mar 2017.
- Background: PubMed 24937085Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV. Effect of smoking on the pharmacokinetics of inhaled loxapine. Ther Drug Monit. 2014 Oct;36(5):618-23. doi: 10.1097/FTD.0000000000000048.
- 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 R. Stoltz, MD principal investigator
Covance Clincial Research Unit, 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 Loxapine 10 mg in people with Smoking, Cigarette, 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 3 inclusion and 3 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 15 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. 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?
Noncompartmental Pharmacokinetic parameters (time frame: 24 hours). 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 NCT00873769, 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 15 Mar 2017.