Clinical trial NCT00874237: Staccato Loxapine Thorough QT/QTc Study
Official title: Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thorough QT/QTc Study
Keywords: Staccato loxapine
QT/QTc
healthy volunteers
Thorough QT/QTc study
ADASUVE
inhaled loxapine
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
timeFrame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Secondary outcomes:
measure: Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.
timeFrame: 24 hours
measure: Numbers and % of Subjects With QTcI > 450 ms
timeFrame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
measure: Numbers and % of Subjects With QTcI > 480 ms
timeFrame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
measure: Numbers and % of Subjects With QTcI Change > 30 ms
timeFrame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
measure: Numbers and % of Subjects With QTcI Change > 60 ms
timeFrame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Other outcomes:
measure: Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)
timeFrame: 1, 1.5, 2, 2.5, 3, 5, 8, 12, and 24 hr
Locations:
city: Evansville
country: United States
facility: Covance Clinical Research Unit Inc.
state: Indiana
Study officials:
affiliation: Covance
name: Randall R. Stoltz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.