Staccato Loxapine Thorough QT/QTc Study

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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