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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: June 22, 2009
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.
April 1, 2009
April 2, 2009
June 22, 2009
April 2009
June 2009   (Final data collection date for primary outcome measure)
Time-matched average differences in QTc between active drug and placebo [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT00874237 on ClinicalTrials.gov Archive Site
QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers. [ Time Frame: 24 hours ]
Same as current
Not Provided
Not Provided
 
Staccato Loxapine Thorough QT/QTc
Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy
  • Drug: 1 (Staccato Loxapine)
    Staccato Loxapine
  • Drug: 2 (Moxifloxacin)
    Oral moxifloxacin
  • Drug: 3 (Placebo)
    Placebo
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00874237
AMDC-004-107
February 26, 2009
No
Not Provided
Not Provided
Robert Fishman, MD, Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Randall R. Stoltz, MD Covance
Alexza Pharmaceuticals, Inc.
June 2009

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