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Staccato Loxapine Thorough QT/QTc

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874237
First Posted: April 2, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alexza Pharmaceuticals, Inc.
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers. [ Time Frame: 24 hours ]

Enrollment: 46
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Staccato Loxapine
Drug: 1 (Staccato Loxapine)
Staccato Loxapine
Active Comparator: 2
Oral moxifloxacin
Drug: 2 (Moxifloxacin)
Oral moxifloxacin
Placebo Comparator: 3
Placebo
Drug: 3 (Placebo)
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874237


Locations
United States, Indiana
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
Principal Investigator: Randall R. Stoltz, MD Covance
  More Information

Responsible Party: Robert Fishman, MD, Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00874237     History of Changes
Other Study ID Numbers: AMDC-004-107
February 26, 2009
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: October 12, 2017
Last Verified: June 2009

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato loxapine
QTc
healthy volunteers

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Loxapine
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents