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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04327765

Enrollment

Registered

2020-03-31

Start date

2020-03-10

Completion date

2020-08-15

Last updated

2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

COMBINATION_PRODUCT0.5mg AZ-010

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

COMBINATION_PRODUCT1mg AZ-010

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

COMBINATION_PRODUCT3mg AZ-010

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Measurement of Granisetron Exposure in Plasma	8 days	AUC
Measurement of Granisetron Maximum exposure in Plasma	8 days	Cmax
Measurement of Granisetron Time to Maximum Exposure in Plasma	8 days	Tmax

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026