Staccato® Granisetron Multiple Dose PK

Phase 1

Completed

• Conditions: Healthy
• Interventions: Combination Product: 0.5mg AZ-010; Combination Product: 3mg AZ-010; Combination Product: 1mg AZ-010

• Registration Number: NCT04327765
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

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

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-10
• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Primary Completion: 2020-08-04
• Study Completion: 2020-08-15
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	0.5mg AZ-010	Single orally-inhaled dose
Cohort 3	3mg AZ-010	Single orally-inhaled dose
Cohort 2	1mg AZ-010	Single orally-inhaled dose

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Measurement of Granisetron Exposure in Plasma	8 days	AUC
Measurement of Granisetron Time to Maximum Exposure in Plasma	8 days	Tmax
Measurement of Granisetron Maximum exposure in Plasma	8 days	Cmax

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States