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Staccato Prochlorperazine Thorough QT/QTc

NCT00543062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-03-11

Study results available
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Summary

To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.

Conditions

Interventions

DRUG

Inhaled placebo

Inhaled Staccato placebo (0 mg)

DRUG

Oral placebo

Oral placebo (identical to 400 mg moxifloxacin)

DRUG

Inhaled prochlorperazine 5 mg

Staccato prochlorperazine 5 mg, single dose

DRUG

Inhaled prochlorperazine 10 mg

Inhaled prochlorperazine 10 mg, single dose

DRUG

Oral moxifloxacin

Oral moxifloxacin 400 mg, si/ngle dose

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Randall R Stoltz, MD · Covance GFI Research, Evansville, IN 47714

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
2007-10-31
Primary Completion
2007-12-31
Completion
2007-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00543062 on ClinicalTrials.gov