Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269035
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2005-12-21
Brief Title:
SPECT Study With SB-773812 In Schizophrenic Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Parallel Study to Investigate Dopaminergic D2 and Serotoninergic 5HT2A Receptor Occupancy at Stable Plasma Concentrations of SB-773812 After Repeated Doses in Schizophrenic Patients Relationship With Pharmacokinetics and Efficacy Readouts
Status:
COMPLETED
Status Verified Date:
2017-08
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 being conducted in 2 groups of schizophrenic patients in group 1 the relationship between the dopaminergic D2 receptor occupancy D2 RO and serotoninergic 5HT2A receptor occupancy at stable plasma concentration Cp of SB-773812 will be investigated using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design In group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at least 10 patients showing clinical improvement with SB-773812 The relationship of D2 RO measured at steady state after chronic dosing at Cmax 6-2 h and Ctrough 24-4 h and PK at steady state after repeated doses to efficacy readouts will be investigated The SB-773812 dose administered will be selected as the highest dose proven to be safe and well tolerated from a previous study
Detailed Description:
None
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