Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2009-04-30
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Staccato Prochlorperazine Thorough QT/QTc
NCT00543062
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
NCT01461460
Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart
NCT05933447
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants
NCT06194032
A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants
NCT05668936
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment sequence ABC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Treatment sequence ACB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Treatment sequence BCA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Treatment sequence BAC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Treatment sequence CAB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Treatment sequence CBA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inhaled loxapine
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebo
Inhaled Staccato placebo single dose
Oral moxifloxacin
Oral moxifloxacin 400 mg
Oral placebo
Oral placebo similar in appearance to moxifloxacin 400 mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alexza Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Randall R. Stoltz, MD
Role: PRINCIPAL_INVESTIGATOR
Covance
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
February 26, 2009
Identifier Type: -
Identifier Source: secondary_id
AMDC-004-107
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.