Staccato Loxapine QT/QTc Study

This study is currently recruiting participants.

Verified by Alexza Pharmaceuticals, Inc., April 2009

First Received: April 1, 2009 No Changes Posted

Sponsored by:	Alexza Pharmaceuticals, Inc.
Information provided by:	Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00874237

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: 1 (Staccato Loxapine) Drug: 2 (Moxifloxacin) Drug: 3 (Placebo)	Phase I

Drug Information available for: Loxapine succinate Loxapine hydrochloride Moxifloxacin Moxifloxacin hydrochloride Loxapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety Study
Official Title:	Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	48
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Staccato Loxapine	Drug: 1 (Staccato Loxapine) Staccato Loxapine
2: Active Comparator Oral moxifloxacin	Drug: 2 (Moxifloxacin) Oral moxifloxacin
3: Placebo Comparator Placebo	Drug: 3 (Placebo) Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874237

Contacts

Contact: Robert S. Fishman, MD	650 944 7000	rfishman@alexza.com
Contact: Laura E. Mei	650 944 7474	lmei@alexza.com

Locations

United States, Indiana
Covance Clinical Research Unit Inc.	Recruiting
Evansville, Indiana, United States, 47710
Contact: Randall R. Stoltz, MD 812-469-5000 randall.stoltz@covance.com
Contact: Angela Ashbrook, BS 812 469 5036 angela.ashbrook@covance.com
Principal Investigator: Randall R. Stoltz, MD

Sponsors and Collaborators

Alexza Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Randall R. Stoltz, MD

Covance Clinical Research Unit Inc.

More Information

No publications provided

Responsible Party:	Alexza Pharmaceuticals, Inc. ( Robert Fishman, MD )
Study ID Numbers:	AMDC-004-107, February 26, 2009
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874237 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:

Staccato loxapine
QTc
healthy volunteers

Study placed in the following topic categories:

Neurotransmitter Agents
Dopamine
Tranquilizing Agents
Moxifloxacin
Psychotropic Drugs

Loxapine
Central Nervous System Depressants
Dopamine Agents
Healthy
Antipsychotic Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Moxifloxacin
Therapeutic Uses
Loxapine
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009