Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585163
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Study to Investigate the Safety Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Crossover Study to Evaluate the Safety Tolerability and Pharmacokinetics of QEV-817 Oral Suspension in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study has been designed to assess the safety tolerability and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked
Detailed Description:
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 11 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 ie 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
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 11 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None