Staccato Loxapine Thorough QT/QTc
Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: 1 (Staccato Loxapine) (Drug); 2 (Moxifloxacin) (Drug); 3 (Placebo) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alexza Pharmaceuticals, Inc. Official(s) and/or principal investigator(s):
Randall R. Stoltz, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit Inc.
Summary
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.
Clinical Details
Official title: Thorough QT/QTc Study of StaccatoŽ Loxapine for Inhalation in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Time-matched average differences in QTc between active drug and placebo
Secondary outcome: QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Covance Clinical Research Unit Inc., Evansville, Indiana 47710, United States
Additional Information
Starting date: April 2009
Last updated: June 18, 2009
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