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OpenTrials
Completed

NCT Number: NCT04327765

Staccato® Granisetron Multiple Dose PK

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.5mg AZ-010

Combination Product

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

Other names: Staccato Placebo

1mg AZ-010

Combination Product

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

Other names: Staccato Placebo

3mg AZ-010

Combination Product

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

Other names: Staccato Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Measurement of Granisetron Exposure in Plasma

    Time frame: 8 days

    AUC

  2. Measurement of Granisetron Maximum exposure in Plasma

    Time frame: 8 days

    Cmax

  3. Measurement of Granisetron Time to Maximum Exposure in Plasma

    Time frame: 8 days

    Tmax

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Collaborators

  • Celerion

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2020
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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