Staccato® Granisetron Single Dose PK
Public ClinicalTrials.gov record NCT04200092. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label. The primary objectives for each part were as follows: Part A: 1. To examine the tolerability and safety of single ascending doses up to 3 mg of AZ-010 (Staccato Granisetron) in healthy volunteers 2. To characterize the pharmacokinetics (PK) of single ascending doses up to 3 mg of AZ-010 in healthy volunteers Part B: 1\. To compare the PK and safety of a single dose of 1 mg of AZ-010 with that of 1 mg granisetron hydrochloride intravenous (IV) injection in healthy volunteers. The 2 parts to the study were performed sequentially.
Study identification
- NCT ID
- NCT04200092
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Interventions
- 0.5mg AZ-010; placebo Combination Product
- 1mg AZ-010 Combination Product
- 3mg AZ-010 Combination Product
- AZ-010 1mg Combination Product
- IV Granisetron 1mg Drug
- Placebo Other
Combination Product · Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 3, 2019
- Primary completion
- Jan 9, 2020
- Completion
- Jan 30, 2020
- Last update posted
- Apr 12, 2026
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04200092, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04200092 live on ClinicalTrials.gov.