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Staccato® Granisetron Multiple Dose PK

NCT ID: NCT04327765

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-08-15

Brief Summary

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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

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Single orally-inhaled dose

Group Type EXPERIMENTAL

0.5mg AZ-010

Intervention Type COMBINATION_PRODUCT

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

Cohort 2

Single orally-inhaled dose

Group Type EXPERIMENTAL

1mg AZ-010

Intervention Type COMBINATION_PRODUCT

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

Cohort 3

Single orally-inhaled dose

Group Type EXPERIMENTAL

3mg AZ-010

Intervention Type COMBINATION_PRODUCT

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

Interventions

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0.5mg AZ-010

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

Intervention Type COMBINATION_PRODUCT

1mg AZ-010

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

Intervention Type COMBINATION_PRODUCT

3mg AZ-010

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Staccato Placebo Staccato Placebo Staccato Placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celerion

INDUSTRY

Sponsor Role collaborator

Alexza Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terry O'Reilly, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

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Celerion

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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AMDC-010-102

Identifier Type: -

Identifier Source: org_study_id