Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01827631
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2013-04-05
Brief Title:
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
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:
This is an open-label parallel group single and repeat dose pharmacokinetic PK study in healthy male and female subjects This study will confirm the PK and safety profile in Chinese subjects GSK1605786 is currently in clinical development for the treatment of Crohns disease Subjects will receive one of two GSK1605786 doses 500 mg once daily or 500mg twice daily within 30 minutes after a meal The study will consist of single and repeat dose sessions with pre-dose and serial PK samples taken up to 72-h post-dose
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