Staccato® Granisetron Multiple Dose PK

October 29, 2020 updated by: Alexza Pharmaceuticals, Inc.

A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1
Single orally-inhaled dose
Combination product: 0.5mg AZ-010
Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
Other Names:
  • Staccato Placebo
EXPERIMENTAL: Cohort 2
Single orally-inhaled dose
Combination product: 1mg AZ-010
Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
Other Names:
  • Staccato Placebo
EXPERIMENTAL: Cohort 3
Single orally-inhaled dose
Combination product: 3mg AZ-010
Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo
Other Names:
  • Staccato Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame: 8 days
Number of Subjects with Adverse Events as a measure of Safety and Tolerability
8 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Collaborators

Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2020

Primary Completion (ACTUAL)

August 4, 2020

Study Completion (ACTUAL)

August 15, 2020

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (ACTUAL)

March 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AMDC-010-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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