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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

Page last updated: August 23, 2015

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