Thorough QT/QTc StudyPhase 1NCT00874237
Staccato Loxapine Thorough QT/QTc Study
A Phase 1 study testing Inhaled loxapine and Oral moxifloxacin in people with Thorough QT/QTc Study, run by Nova Pneuma Inc. at 1 site in United States.
Trial summary
The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thorough QT/QTc Study
- What is being tested?
- Inhaled loxapine and Oral moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.
Who cannot join
- Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
- Subjects who have had an acute illness within the last 5 days of treatment,
- Subjects who are smokers, OR
- Subjects who have an ECG abnormality at baseline.
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: Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.
Read the detailed description
Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.
Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.
- Conditions
- Thorough QT/QTc Study
- Being tested
- Inhaled loxapine, Inhaled placebo, Oral moxifloxacin, Oral placebo
- Keywords
- Staccato loxapine, QT/QTc, healthy volunteers, Thorough QT/QTc study, ADASUVE, inhaled loxapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled loxapineDrug
Also called ADASUVE
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placeboDrug
Inhaled Staccato placebo single dose
Oral moxifloxacinDrug
Oral moxifloxacin 400 mg
Oral placeboDrug
Oral placebo similar in appearance to moxifloxacin 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence ABC | Other | Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg Receives: Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral moxifloxacin; Drug: Oral placebo |
| Treatment sequence ACB | Other | Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg Receives: Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral moxifloxacin; Drug: Oral placebo |
| Treatment sequence BCA | Other | Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg Receives: Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral moxifloxacin; Drug: Oral placebo |
| Treatment sequence BAC | Other | Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg Receives: Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral moxifloxacin; Drug: Oral placebo |
| Treatment sequence CAB | Other | Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg Receives: Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral moxifloxacin; Drug: Oral placebo |
| Treatment sequence CBA | Other | Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg Receives: Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral moxifloxacin; Drug: Oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
Largest of the upper CIs of the time matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time matched placebo subtraction for ADASUVE treatment at 12 prespecified post inhalation times
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Secondary outcomes (5)
Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.
QTcI change at the median loxapine concentration (32.2 mcg/mL) based on nonlinear regression of QTcI versus log of time matched serum loxapine concentrations. This analysis looks for repolarization versus concentration relationship in a positive or negative thorough QT/QTc study result.
Measured: 24 hours
Numbers and % of Subjects With QTcI > 450 ms
Numbers and Percents of Subjects with QTcI exceeding 450 ms
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Numbers and % of Subjects With QTcI > 480 ms
Numbers and Percents of Subjects with QTcI exceeding 480 ms
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Numbers and % of Subjects With QTcI Change > 30 ms
Numbers and Percents of Subjects with QTcI increase from baseline exceeding 30 ms
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Numbers and % of Subjects With QTcI Change > 60 ms
Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms
Measured: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thorough QT/QTc StudyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Pneuma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Randall R. Stoltz, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874237
- Sponsor's protocol ID
- AMDC-004-107
- Other IDs
- February 26, 2009
- Status last verified
- Oct 2019
- First submitted
- 1 Apr 2009
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 ClinicalTrialsDoc@alexza.com
Publications
Spyker DA, Voloshko P, Heyman ER, Cassella JV. Loxapine delivered as a thermally generated aerosol does not prolong QTc in a thorough QT/QTc study in healthy subjects. J Clin Pharmacol. 2014 Jun;54(6):665-74. doi: 10.1002/jcph.257. Epub 2014 Jan 22.
PubMed 24375070
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00874237
- Acronym / sponsor ID
- AMDC-004-107
- Conditions
- Thorough QT/QTc Study
- Keywords
- Staccato loxapine, QT/QTc, healthy volunteers, Thorough QT/QTc study, ADASUVE, inhaled loxapine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nova Pneuma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 30 Oct 2019
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 present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.
Detailed description
Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.
Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence ABC | Other | Drug: Inhaled loxapine, Drug: Inhaled placebo, Drug: Oral moxifloxacin, Drug: Oral placeboTreatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg |
| Treatment sequence ACB | Other | Drug: Inhaled loxapine, Drug: Inhaled placebo, Drug: Oral moxifloxacin, Drug: Oral placeboTreatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg |
| Treatment sequence BCA | Other | Drug: Inhaled loxapine, Drug: Inhaled placebo, Drug: Oral moxifloxacin, Drug: Oral placeboTreatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg |
| Treatment sequence BAC | Other | Drug: Inhaled loxapine, Drug: Inhaled placebo, Drug: Oral moxifloxacin, Drug: Oral placeboTreatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg |
| Treatment sequence CAB | Other | Drug: Inhaled loxapine, Drug: Inhaled placebo, Drug: Oral moxifloxacin, Drug: Oral placeboTreatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg |
| Treatment sequence CBA | Other | Drug: Inhaled loxapine, Drug: Inhaled placebo, Drug: Oral moxifloxacin, Drug: Oral placeboTreatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.
Key exclusion criteria (4 listed)
- Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
- Subjects who have had an acute illness within the last 5 days of treatment,
- Subjects who are smokers, OR
- Subjects who have an ECG abnormality at baseline.
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 loxapineAlso: ADASUVEInhaled Staccato Loxapine 10 mg single dose | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
| Inhaled placeboInhaled Staccato placebo single dose | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
| Oral moxifloxacinOral moxifloxacin 400 mg | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
| Oral placeboOral placebo similar in appearance to moxifloxacin 400 mg | Drug | Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA |
Primary outcome
Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Largest of the upper CIs of the time matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time matched placebo subtraction for ADASUVE treatment at 12 prespecified post inhalation times
5 secondary outcomes
Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.
Time frame: 24 hours
Numbers and % of Subjects With QTcI > 450 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Numbers and % of Subjects With QTcI > 480 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Numbers and % of Subjects With QTcI Change > 30 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Numbers and % of Subjects With QTcI Change > 60 ms
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24375070Spyker DA, Voloshko P, Heyman ER, Cassella JV. Loxapine delivered as a thermally generated aerosol does not prolong QTc in a thorough QT/QTc study in healthy subjects. J Clin Pharmacol. 2014 Jun;54(6):665-74. doi: 10.1002/jcph.257. Epub 2014 Jan 22.
- Individual participant dataSharing planned: Yes. IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsDoc@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
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 and Oral moxifloxacin in people with Thorough QT/QTc Study, run by Nova Pneuma 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 4 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 22 Apr 2026. 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 30 Oct 2019). 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?
Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo (time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 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 NCT00874237, 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 22 Apr 2026.