Staccato® Granisetron Multiple Dose PK
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
1 other identifier
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2020
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2020
CompletedFirst Submitted
Initial submission to the registry
March 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2020
CompletedOctober 30, 2020
March 1, 2020
5 months
March 27, 2020
October 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Number of Subjects with Adverse Events as a measure of Safety and Tolerability
8 days
Secondary Outcomes (3)
Measurement of Granisetron Exposure in Plasma
8 days
Measurement of Granisetron Maximum exposure in Plasma
8 days
Measurement of Granisetron Time to Maximum Exposure in Plasma
8 days
Study Arms (3)
Cohort 1
EXPERIMENTALSingle orally-inhaled dose
Cohort 2
EXPERIMENTALSingle orally-inhaled dose
Cohort 3
EXPERIMENTALSingle orally-inhaled dose
Interventions
Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any significant medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexza Pharmaceuticals, Inc.lead
- Celerioncollaborator
Study Sites (1)
Celerion
Tempe, Arizona, 85283, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Terry O'Reilly, MD
Celerion
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2020
First Posted
March 31, 2020
Study Start
March 10, 2020
Primary Completion
August 4, 2020
Study Completion
August 15, 2020
Last Updated
October 30, 2020
Record last verified: 2020-03