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Completed

NCT Number: NCT00874237

Staccato Loxapine Thorough QT/QTc Study

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.

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Key information

Conditions

Thorough QT/QTc Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47710, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inhaled loxapine

Drug

Inhaled Staccato Loxapine 10 mg single dose

Other names: ADASUVE

Inhaled placebo

Drug

Inhaled Staccato placebo single dose

Oral moxifloxacin

Drug

Oral moxifloxacin 400 mg

oral placebo

Drug

Oral placebo similar in appearance to moxifloxacin 400 mg

Primary outcomes

  1. 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

Secondary outcomes

  1. Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.

    Time frame: 24 hours

    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.

  2. 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 Percents of Subjects with QTcI exceeding 450 ms

  3. 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 Percents of Subjects with QTcI exceeding 480 ms

  4. 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 Percents of Subjects with QTcI increase from baseline exceeding 30 ms

  5. 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

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

Other outcomes

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

    Time frame: 1, 1.5, 2, 2.5, 3, 5, 8, 12, and 24 hr

    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

Sponsors and collaborators

Lead sponsor

Nova Pneuma Inc.

Industry

Collaborators

  • Covance

Registry information

Official study title

Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 2, 2009
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.