Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT03809234
Status:
TERMINATED
Last Update Posted:
2022-04-07
First Post:
2019-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pgp Transporter and CNS Biodistribution of Ondansetron in Healthy Volunteers
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Effects of Pgp Transporter Inhibition on CNS Biodistribution of Ondansetron in Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adverse effects related to study procedure (not study drug)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the time-course of plasma and CSF concentrations of intravenous (IV) ondansetron in healthy subjects, with and without selective inhibition of Pgp efflux transporter.
Detailed Description:
The study hypothesis is that inhibition of Pgp efflux transporters will increase the CNS bio-distribution of the 5-HT3R antagonist ondansetron.
Specifically:
1. Intravenous administration of ondansetron is expected to yield low CSF exposure.
2. Co-administration of ondansetron with intravenous tariquidar, an inhibitor of Pgp efflux transporters, will result in increased CSF exposure of ondansetron.
Specifically:
1. Intravenous administration of ondansetron is expected to yield low CSF exposure.
2. Co-administration of ondansetron with intravenous tariquidar, an inhibitor of Pgp efflux transporters, will result in increased CSF exposure of ondansetron.
Study Oversight
Has Oversight DMC:
True
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?: