Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult
male and female volunteers, including 18 smokers and 18 non-smokers. All subjects will be
administered a single inhaled dose of Staccato alprazolam 1 mg via hand-held inhaler. Blood
samples will be drawn for pharmacokinetic analysis. Eligible subjects are admitted to Phase 1
unit for up to 48 hours. Subjects will receive a post-study safety phone call 14 days(± 2
days) after dosing.
Phase:
Phase 1
Details
Lead Sponsor:
Engage Therapeutics, Inc. EngageTherapeutics, Inc.