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ADASUVE 2-dose Thorough QT/QTc Study

NCT01854710 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-10-18

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Teresa Nunes, MD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-07-31
Completion
2013-07-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854710 on ClinicalTrials.gov