NCT01854710

ADASUVE 2-dose Thorough QT/QTc Study

Thorough QT/QTc Study of 2 Doses of ADASUVE® in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

Detailed description

It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers. The study hypothesis H0: Placebo-subtracted max mean dQTc \> 10 msec

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ADASUVE 10 mg 2 doses 2 hours apart	Inhaled loxapine 10 mg 2 doses 2 hours apart
DRUG	Inhaled Placebo	Staccato placebo via inhalation x 2 at 2 hours apart
DRUG	Oral moxifloxacin 400 mg	Oral moxifloxacin 400 mg single dose
DRUG	Oral placebo	Oral capsule identical in appearance to moxifloxacin

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-05-15
• Last updated: 2017-10-18
• Results posted: 2017-10-18

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study