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Staccato® Granisetron Multiple Dose PK

NCT04327765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-30

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

COMBINATION_PRODUCT

0.5mg AZ-010

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 (1mg) of AZ-010 or matching Staccato Placebo

COMBINATION_PRODUCT

3mg AZ-010

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

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Terry O'Reilly, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2020-08-04
Completion
2020-08-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04327765 on ClinicalTrials.gov