Staccato Loxapine Thorough QT/QTc

This study has been completed.

Sponsor:

Information provided by:

Alexza Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00874237

First received: April 1, 2009

Last updated: June 18, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2009

Last Updated Date

June 18, 2009

Start Date ^ICMJE

April 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time-matched average differences in QTc between active drug and placebo [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00874237 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Staccato Loxapine Thorough QT/QTc

Official Title ^ICMJE

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

Brief Summary

The purpose of the present Phase 1 study is to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: 1 (Staccato Loxapine)
Staccato Loxapine
Drug: 2 (Moxifloxacin)
Oral moxifloxacin
Drug: 3 (Placebo)
Placebo

Study Arm (s)

Experimental: 1
Staccato Loxapine

Intervention: Drug: 1 (Staccato Loxapine)
Active Comparator: 2
Oral moxifloxacin

Intervention: Drug: 2 (Moxifloxacin)
Placebo Comparator: 3
Placebo

Intervention: Drug: 3 (Placebo)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00874237

Other Study ID Numbers ^ICMJE

AMDC-004-107, February 26, 2009

Has Data Monitoring Committee

Responsible Party

Robert Fishman, MD, Alexza Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Alexza Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Randall R. Stoltz, MD

Covance Clinical Research Unit Inc.

Information Provided By

Alexza Pharmaceuticals, Inc.

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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