Staccato® Granisetron Multiple Dose PK

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Combination Product: 3mg AZ-010; Combination Product: 1mg AZ-010; Combination Product: 0.5mg AZ-010

Study type: Interventional

Funder types: Industry

Identifiers

NCT04327765

AMDC-010-102

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Single orally-inhaled dose

Treatment:

Combination Product: 0.5mg AZ-010

Cohort 2

Experimental group

Description:

Single orally-inhaled dose

Treatment:

Combination Product: 1mg AZ-010

Cohort 3

Experimental group

Description:

Single orally-inhaled dose

Treatment:

Combination Product: 3mg AZ-010