Staccato® Granisetron Multiple Dose PK

NCT04327765 — Phase 1, Completed, 30 participants, Alexza Pharmaceuticals, Inc.

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

Registry	NCT04327765
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, sequential, masking: triple, treatment
Enrollment	30 (Actual)
Sponsor	Alexza Pharmaceuticals, Inc. (Unknown); collaborators: Celerion
Conditions	Healthy
Interventions	0.5mg AZ-010, 1mg AZ-010, 3mg AZ-010 (Combination product)
Dates	start 2020-03-10, primary completion 2020-08-04, completion 2020-08-15, first posted 2020-03-31, last updated 2020-10-30
Locations	1 site in United States

-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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Cohort 1	Experimental	Combination Product: 0.5mg AZ-010	Single orally-inhaled dose
Cohort 2	Experimental	Combination Product: 1mg AZ-010	Single orally-inhaled dose
Cohort 3	Experimental	Combination Product: 3mg AZ-010	Single orally-inhaled dose

0.5mg AZ-010 (Combination product), also known as Staccato Placebo: Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
1mg AZ-010 (Combination product), also known as Staccato Placebo: Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
3mg AZ-010 (Combination product), also known as Staccato Placebo: Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo

+Outcome measures

Primary outcomes

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

Secondary outcomes

Measurement of Granisetron Exposure in Plasma [8 days]: AUC
Measurement of Granisetron Maximum exposure in Plasma [8 days]: Cmax
Measurement of Granisetron Time to Maximum Exposure in Plasma [8 days]: Tmax

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Celerion	Tempe, Arizona	United States

+Investigators

Terry O'Reilly, MD, Principal investigator, Celerion