Staccato® Granisetron Single Dose PK

Study Overview
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Brief Summary
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Part A: Single Ascending Dose in Healthy Volunteers This study will assess single ascending oral doses of AZ-010 in a placebo-controlled, double-blind design. The planned AZ-010 doses to be studied are 0.5 mg, 1 mg, and 3 mg. Part B: Single Dose Crossover in Healthy Volunteers 2-period, 2-treatment open-label crossover design study assessing the pharmacokinetic profiles of AZ-010 (1 mg) and granisetron for IV injection (1 mg).

Detailed Description
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This two-part study will assess the safety, tolerability, and pharmacokinetics (PK) of single ascending doses AZ-010 in healthy volunteers and will compare in a crossover design the safety and PK of a single dose of AZ-010 and IV granisetron.

Official Title
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A Two Part Study Investigating the Safety and pk of Single Ascending Doses of Staccato Granisetron (AZ-010) and Crossover Comparison of the Pharmacokinetics and Safety of AZ-010 and Intravenous Granisetron in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Combination Product: 0.5mg AZ-010
* Combination Product: 1mg AZ-010
* Combination Product: 3mg AZ-010
* Combination Product: AZ-010 1mg
* Drug: IV Granisetron 1mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single orally-inhaled dose | Combination Product: 0.5mg AZ-010<br>* Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo<br>* Other names: Staccato Placebo;|
| Experimental: Cohort 2<br>Single orally-inhaled dose | Combination Product: 1mg AZ-010<br>* Subject will receive a single inhaled dose (1.0 mg) of AZ-010 or matching Staccato Placebo<br>* Other names: Staccato Placebo;|
| Experimental: Cohort 3<br>Single orally-inhaled dose | Combination Product: 3mg AZ-010<br>* Subject will receive a single inhaled dose (3.0 mg) of AZ-010 or matching Staccato Placebo<br>* Other names: Staccato Placebo;|
| Experimental: Sequence 1<br>Single orally-inhaled dose | Combination Product: AZ-010 1mg<br>* 2-period, 2-treatment open-label crossover design<br>|
| Active Comparator: Sequence 2<br>Single IV administered dose | Drug: IV Granisetron 1mg<br>* 2-period, 2-treatment open-label crossover design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). | Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | 3 days | 
| Measurement of Granisetron Exposure in Plasma | AUC (area under the curve) | 3 days | 
| Measurement of Granisetron Maximum Exposure in Plasma | Cmax | 3 days | 
| Measurement of Granisetron Time to Maximum Exposure in Plasma | Tmax | 3 days |