Staccato® Granisetron Multiple Dose PK

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327765
• Other study ID #: AMDC-010-102
• Status: Completed
• Phase: Phase 1
• Start date: March 10, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: March 2020
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 15, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Combination Product:
• 0.5mg AZ-010
Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
• 1mg AZ-010
Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
• 3mg AZ-010
Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.	Celerion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of Granisetron Exposure in Plasma	AUC	8 days
Secondary	Measurement of Granisetron Maximum exposure in Plasma	Cmax	8 days
Secondary	Measurement of Granisetron Time to Maximum Exposure in Plasma	Tmax	8 days