Staccato Loxapine Thorough QT/QTc Study

Alexza Pharmaceuticals, Inc.48 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Thorough QT/QTc Study

Interventions

Inhaled loxapineDRUG

Inhaled Staccato Loxapine 10 mg single dose

Inhaled placeboDRUG

Inhaled Staccato placebo single dose

Oral moxifloxacinDRUG

Oral moxifloxacin 400 mg

Oral placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance Clinical Research Unit Inc.

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Secondary 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.

Time frame: 24 hours

Numbers and % of Subjects With QTcI > 450 ms

Numbers and Percents of Subjects with QTcI exceeding 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

Numbers and Percents of Subjects with QTcI exceeding 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

Numbers and Percents of Subjects with QTcI increase from baseline exceeding 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

Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms

Data from ClinicalTrials.gov

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