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

April 1, 2009
June 18, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00874237
AMDC-004-107, February 26, 2009
No
Robert Fishman, MD, Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Randall R. Stoltz, MD Covance Clinical Research Unit Inc.
Alexza Pharmaceuticals, Inc.
June 2009

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