NCT04327765

Staccato® Granisetron Multiple Dose PK

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	0.5mg AZ-010	Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
COMBINATION_PRODUCT	1mg AZ-010	Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
COMBINATION_PRODUCT	3mg AZ-010	Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo

Timeline

• Start date: 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 across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study