Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension

This is a Phase 1, single-center, double-blind, randomized crossover study that will be conducted in male and female healthy volunteers. The study will be conducted at a single site in the US. The study consists of a 28-day Screening Period, a four-day treatment period, and a one-day safety follow-up period.

The study will be conducted in eight (8) healthy male and female subjects. Up to an additional five (5) subjects may be enrolled as alternates to replace dropouts. Subjects will be randomized (1:1) to one of two crossover treatment sequences.

The subjects, Investigators, and site personnel (except site personnel responsible for study treatment preparation) will be blinded to treatment assignments. Subjects will receive either a fixed therapeutic dose of oral hydrocodone alone or in combination with a fixed dose of oral doxapram. Prior to treatment, all subjects will receive naltrexone (opioid antagonist) to block opioid effects (i.e., naltrexone block).

Safety will be evaluated by monitoring the nature, severity, and incidence of adverse events (AEs); and changes from baseline in physical examination, vital signs, 12-lead electrocardiogram (ECG) assessment, pulse oximetry, and clinical laboratory tests.

Pharmacokinetics of both drugs and their primary metabolites will be assessed in plasma samples collected through 24 hours post-dose from all subjects. All enrolled subjects will also be genotyped for CYP2D6 polymorphism status.