Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759768
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2021-02-15
Brief Title:
Pharmacokinetic Evaluation of Intranasal Nalmefene
Sponsor:
Opiant Pharmaceuticals Inc
Organization:
Opiant Pharmaceuticals Inc
Study Overview
Official Title:
Two-Period Two-Treatment Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to determine the pharmacokinetics how the body absorbs breaks down and eliminates drug from your body of nalmefene when given intranasally INinto the nose compared to a dose of nalmefene when given intramuscularly IM into the muscle to compare the blood levels of nalmefene when given IN to nalmefene when given IM and to evaluate the safety and tolerability of nalmefene IN
Detailed Description:
Open-label randomized 2-period 2-treatment 2-sequence crossover study in 68 healthy volunteers Subjects will be assigned to each of the 2 possible sequences Each subject will receive 2 treatments during the 2 dosing periods Intranasal IN dose of 3 mg nalmefene hydrochloride and intramuscular IM dose of 10 mg nalmefene with a 4 day washout period between doses Screening can occur up to 28 days before baseline admission subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events AEs and concomitant medications since discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None