Staccato® Granisetron Multiple Dose PK

Alexza Pharmaceuticals, Inc.30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

0.5mg AZ-010COMBINATION_PRODUCT

Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo

1mg AZ-010COMBINATION_PRODUCT

Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo

3mg AZ-010COMBINATION_PRODUCT

Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Celerion

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

Number of Subjects with Adverse Events as a measure of Safety and Tolerability

Time frame: 8 days

Secondary Outcomes

Measurement of Granisetron Exposure in Plasma

AUC

Time frame: 8 days

Measurement of Granisetron Maximum exposure in Plasma

Cmax

Time frame: 8 days

Measurement of Granisetron Time to Maximum Exposure in Plasma

Tmax

Time frame: 8 days

Data from ClinicalTrials.gov

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