Page last updated: 2024-10-30

loxapine and Electrocardiogram QT Prolonged

loxapine has been researched along with Electrocardiogram QT Prolonged in 1 studies

Loxapine: An antipsychotic agent used in SCHIZOPHRENIA.

Research

Studies (1)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Spyker, DA	1
Voloshko, P	1
Heyman, ER	1
Cassella, JV	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers[NCT00874237]			Phase 1	48 participants (Actual)	Interventional	2009-04-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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. (NCT00874237)
Timeframe: 24 hours

Intervention	mseconds (Least Squares Mean)
Inhaled Loxapine 10 mg	4.238

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 (NCT00874237)
Timeframe: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Intervention	mseconds (Least Squares Mean)
Inhaled Loxapine 10 mg vs Placebo Crossover Subjects	5.418

Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)

A thorough QT/QTc study may be considered to have demonstrated assay sensitivity if 1 or more of the lower 95% CI values exceeds 5 msec ant any of the 9 predetermined time points (NCT00874237)
Timeframe: 1, 1.5, 2, 2.5, 3, 5, 8, 12, and 24 hr

Intervention	mseconds (Least Squares Mean)
Oral Moxifloxacin vs Placebo Crossover Subjects	8.356

Numbers and % of Subjects With QTcI > 450 ms

Numbers and Percents of Subjects with QTcI exceeding 450 ms (NCT00874237)
Timeframe: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Intervention	Participants (Count of Participants)
Inhaled Loxapine 10 mg	1
Inhaled Placebo	1

Numbers and % of Subjects With QTcI > 480 ms

Numbers and Percents of Subjects with QTcI exceeding 480 ms (NCT00874237)
Timeframe: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Intervention	Participants (Count of Participants)
Inhaled Loxapine 10 mg	0
Inhaled Placebo	0

Numbers and % of Subjects With QTcI Change > 30 ms

Numbers and Percents of Subjects with QTcI increase from baseline exceeding 30 ms (NCT00874237)
Timeframe: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Intervention	Participants (Count of Participants)
Inhaled Loxapine 10 mg	1
Inhaled Placebo	1

Numbers and % of Subjects With QTcI Change > 60 ms

Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms (NCT00874237)
Timeframe: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Intervention	Participants (Count of Participants)
Inhaled Loxapine 10 mg	0
Inhaled Placebo	0

Trials

1 trial available for loxapine and Electrocardiogram QT Prolonged

Article	Year
Loxapine delivered as a thermally generated aerosol does not prolong QTc in a thorough QT/QTc study in healthy subjects. Journal of clinical pharmacology, 2014, Volume: 54, Issue:6 Topics: Administration, Inhalation; Adolescent; Adult; Aerosols; Aged; Antipsychotic Agents; Blood Pressure;	2014