Staccato Loxapine PK in Smokers and Nonsmokers | NCT00873769

Studies
Staccato Loxapine PK in Smokers and Nonsmokers

NCT00873769

Sponsor

Alexza Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Mar 15, 2017Actual

Enrollment

35Actual

Phase

Phase 1

Conditions

Smoking, Cigarette

Interventions

Inhaled Loxapine 10 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
27 February 2009

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Apr 1, 2009

First Submission Date that Met QC Criteria

Apr 1, 2009

First Posted Date

Apr 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2017

Last Update Posted Date

Mar 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.

Detailed Description

Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy smokers	Experimental	Healthy smokers, male and female	Drug: Inhaled Loxapine 10 mg
Healthy nonsmokers	Experimental	Healthy nonsmokers, Healthy smokers, male and female	Drug: Inhaled Loxapine 10 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inhaled Loxapine 10 mg	Drug	Staccato Loxapine 10 mg, single dose	Healthy nonsmokers Healthy smokers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Noncompartmental Pharmacokinetic parameters		24 hours

Secondary Outcomes

Measure	Description	Time Frame
Vital signs		24 hours
Treatment emergent adverse events		24 hours
Sedation visual analog scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.

Exclusion Criteria:

Any acute illness in the 5 days,
Use of a bronchodilator for the treatment of wheezing within 12 months, OR
Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randall R. Stoltz, MD	Covance Clincial Research Unit, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Clinical Research Unit, Inc.		Evansville	Indiana	47710	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24937085	Background	Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV. Effect of smoking on the pharmacokinetics of inhaled loxapine. Ther Drug Monit. 2014 Oct;36(5):618-23. doi: 10.1097/FTD.0000000000000048.

ID	Term
D000073869	Tobacco Smoking
D012907	Smoking
D001519	Behavior
D064424	Tobacco Use