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Staccato Loxapine Thorough QT/QTc Study

NCT00874237 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-22

Study results available
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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.

Conditions

  • Thorough QT/QTc Study

Interventions

DRUG

Inhaled placebo

Inhaled Staccato placebo single dose

DRUG

Oral moxifloxacin

Oral moxifloxacin 400 mg

DRUG

Oral placebo

Oral placebo similar in appearance to moxifloxacin 400 mg

DRUG

Inhaled loxapine

Inhaled Staccato Loxapine 10 mg single dose

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Nova Pneuma Inc.

    lead INDUSTRY

Principal Investigators

  • Randall R. Stoltz, MD · Covance

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-06-30
Completion
2009-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00874237 on ClinicalTrials.gov