Staccato Loxapine Thorough QT/QTc Study

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Thorough QT/QTc Study

Treatments: Drug: Oral moxifloxacin; Drug: Inhaled loxapine; Drug: Inhaled placebo; Drug: Oral placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00874237

AMDC-004-107

February 26, 2009

Details and patient eligibility

About

The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.

Full description

Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.

Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 6 patient groups

Treatment sequence ABC

Other group

Description:

Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Treatment:

Drug: Oral placebo

Drug: Inhaled placebo

Drug: Inhaled loxapine

Drug: Oral moxifloxacin

Treatment sequence ACB

Other group

Description:

Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Treatment:

Drug: Oral placebo

Drug: Inhaled placebo

Drug: Inhaled loxapine

Drug: Oral moxifloxacin

Treatment sequence BCA

Other group

Description:

Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Treatment:

Drug: Oral placebo

Drug: Inhaled placebo

Drug: Inhaled loxapine

Drug: Oral moxifloxacin

Treatment sequence BAC

Other group

Description:

Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Treatment:

Drug: Oral placebo

Drug: Inhaled placebo

Drug: Inhaled loxapine

Drug: Oral moxifloxacin

Treatment sequence CAB

Other group

Description:

Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Treatment:

Drug: Oral placebo

Drug: Inhaled placebo

Drug: Inhaled loxapine

Drug: Oral moxifloxacin

Treatment sequence CBA

Other group

Description:

Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg

Treatment:

Drug: Oral placebo

Drug: Inhaled placebo

Drug: Inhaled loxapine

Drug: Oral moxifloxacin