Staccato® Granisetron Multiple Dose PK | NCT04327765

Studies
Staccato® Granisetron Multiple Dose PK

NCT04327765

Sponsor

Alexza Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Oct 30, 2020Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

0.5mg AZ-010
1mg AZ-010
3mg AZ-010

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

Status Module

Record Verification Date

Mar 2020

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

Mar 10, 2020Actual

Primary Completion Date

Aug 4, 2020Actual

Completion Date

Aug 15, 2020Actual

First Submitted Date

Mar 27, 2020

First Submission Date that Met QC Criteria

Mar 27, 2020

First Posted Date

Mar 31, 2020Actual

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

Oct 29, 2020

Last Update Posted Date

Oct 30, 2020Actual

Name	Class
Celerion	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers

Detailed Description

A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental	Single orally-inhaled dose	Combination Product: 0.5mg AZ-010
Cohort 2	Experimental	Single orally-inhaled dose	Combination Product: 1mg AZ-010
Cohort 3	Experimental	Single orally-inhaled dose	Combination Product: 3mg AZ-010

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.5mg AZ-010	Combination Product	Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).	Number of Subjects with Adverse Events as a measure of Safety and Tolerability	8 days

Secondary Outcomes

Measure	Description	Time Frame
Measurement of Granisetron Exposure in Plasma	AUC	8 days
Measurement of Granisetron Maximum exposure in Plasma	Cmax	8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.

Exclusion Criteria:

Any significant medical condition

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Terry O'Reilly, MD	Celerion	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Tempe	Arizona	85283	United States