MedTrace Logo

Staccato® Granisetron Single Dose PK

NCT04200092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-13

No results posted yet for this study

Summary

This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label.

The primary objectives for each part were as follows:

Part A:

1. To examine the tolerability and safety of single ascending doses up to 3 mg of AZ-010 (Staccato Granisetron) in healthy volunteers
2. To characterize the pharmacokinetics (PK) of single ascending doses up to 3 mg of AZ-010 in healthy volunteers

Part B:

1\. To compare the PK and safety of a single dose of 1 mg of AZ-010 with that of 1 mg granisetron hydrochloride intravenous (IV) injection in healthy volunteers.

The 2 parts to the study were performed sequentially.

Conditions

  • Healthy

Interventions

COMBINATION_PRODUCT

0.5mg AZ-010; placebo

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

COMBINATION_PRODUCT

1mg AZ-010

Subject will receive a single inhaled dose (1.0 mg) of AZ-010 or matching Staccato Placebo

COMBINATION_PRODUCT

3mg AZ-010

Subject will receive a single inhaled dose (3.0 mg) of AZ-010 or matching Staccato Placebo

COMBINATION_PRODUCT

AZ-010 1mg

2-period, 2-treatment open-label crossover design

DRUG

IV Granisetron 1mg

2-period, 2-treatment open-label crossover design

OTHER

Placebo

Participants in Part A, Cohorts 1, 2, and 3, double-blind, randomized, and placebo-controlled study who received placebo.

Sponsors & Collaborators

  • Nova Pneuma Inc.

    lead INDUSTRY

  • Celerion

    collaborator INDUSTRY

Principal Investigators

  • Phillip Mathew, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-01-10
Completion
2020-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200092 on ClinicalTrials.gov