Status:
COMPLETED
Staccato® Granisetron Multiple Dose PK
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Collaborating Sponsors:
Celerion
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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...
Detailed Description
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
Eligibility Criteria
Inclusion
- 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
- Any significant medical condition
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04327765
Start Date
March 10 2020
End Date
August 15 2020
Last Update
October 30 2020
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283