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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
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Clinical Research Unit Inc.
  More Information

No publications provided

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
Study First Received: April 1, 2009
Last Updated: June 18, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014