Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT01036061
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2009-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GSK618334 Repeat Dose Study
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Placebo-controlled, Single Blind, Randomized Two Part Study Toinvestigate the Tolerability, Pharmacokinetics, and brainDopamine D3 Receptor Occupancy of Increasing Repeat Doses ofGSK618334 for up to 21 Days in Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2017-06
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:
The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
Detailed Description:
GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.
Study Oversight
Has Oversight DMC:
False
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?: