NCT00874237

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

October 30, 2019

Completed
Last Updated

April 22, 2026

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

April 1, 2009

Results QC Date

March 13, 2017

Last Update Submit

April 6, 2026

Conditions

Thorough QT/QTc Study

Keywords

Staccato loxapineQT/QTchealthy volunteersThorough QT/QTc studyADASUVEinhaled loxapine

Outcome Measures

Primary Outcomes (1)

  • Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo

    Largest of the upper CIs of the time matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time matched placebo subtraction for ADASUVE treatment at 12 prespecified post inhalation times

    1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Secondary Outcomes (5)

  • Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.

    24 hours

  • Numbers and % of Subjects With QTcI > 450 ms

    1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

  • Numbers and % of Subjects With QTcI > 480 ms

    1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

  • Numbers and % of Subjects With QTcI Change > 30 ms

    1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

  • Numbers and % of Subjects With QTcI Change > 60 ms

    1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Other Outcomes (1)

  • Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)

    1, 1.5, 2, 2.5, 3, 5, 8, 12, and 24 hr

Study Arms (6)

Treatment sequence ABC

OTHER

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

Drug: Inhaled loxapineDrug: Inhaled placeboDrug: Oral moxifloxacinDrug: Oral placebo

Treatment sequence ACB

OTHER

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

Drug: Inhaled loxapineDrug: Inhaled placeboDrug: Oral moxifloxacinDrug: Oral placebo

Treatment sequence BCA

OTHER

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

Drug: Inhaled loxapineDrug: Inhaled placeboDrug: Oral moxifloxacinDrug: Oral placebo

Treatment sequence BAC

OTHER

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

Drug: Inhaled loxapineDrug: Inhaled placeboDrug: Oral moxifloxacinDrug: Oral placebo

Treatment sequence CAB

OTHER

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

Drug: Inhaled loxapineDrug: Inhaled placeboDrug: Oral moxifloxacinDrug: Oral placebo

Treatment sequence CBA

OTHER

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

Drug: Inhaled loxapineDrug: Inhaled placeboDrug: Oral moxifloxacinDrug: Oral placebo

Interventions

Inhaled loxapineDRUG

Inhaled Staccato Loxapine 10 mg single dose

Also known as: ADASUVE
Treatment sequence ABCTreatment sequence ACBTreatment sequence BACTreatment sequence BCATreatment sequence CABTreatment sequence CBA
Inhaled placeboDRUG

Inhaled Staccato placebo single dose

Treatment sequence ABCTreatment sequence ACBTreatment sequence BACTreatment sequence BCATreatment sequence CABTreatment sequence CBA
Oral moxifloxacinDRUG

Oral moxifloxacin 400 mg

Treatment sequence ABCTreatment sequence ACBTreatment sequence BACTreatment sequence BCATreatment sequence CABTreatment sequence CBA
Oral placeboDRUG

Oral placebo similar in appearance to moxifloxacin 400 mg

Treatment sequence ABCTreatment sequence ACBTreatment sequence BACTreatment sequence BCATreatment sequence CABTreatment sequence CBA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47710, United States

Location

Related Publications (1)

  • Spyker DA, Voloshko P, Heyman ER, Cassella JV. Loxapine delivered as a thermally generated aerosol does not prolong QTc in a thorough QT/QTc study in healthy subjects. J Clin Pharmacol. 2014 Jun;54(6):665-74. doi: 10.1002/jcph.257. Epub 2014 Jan 22.

    PMID: 24375070RESULT

MeSH Terms

Interventions

LoxapineMoxifloxacin

Intervention Hierarchy (Ancestors)

DibenzoxazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-Ring

Limitations and Caveats

The highest approved inhaled loxapine dose of 10 mg was studied. Supratherapeutic doses were not evaluated because of tolerability concerns in healthy subjects. The inclusion of only healthy subjects is likewise a limitation of this study.

Results Point of Contact

Title
Chief Scientific Officer
Organization
Alexza Pharmaceuticals, Inc
jcassella@alexza.com
650.944.7777

Study Officials

  • Randall R. Stoltz, MD

    Covance

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind, double dummy
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 22, 2026

Results First Posted

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsDoc@alexza.com

Locations

US(1)