Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01611805
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2012-04-12
Brief Title:
Japanese Phase I of GSK1605786
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Placebo-Controlled Four-Period Crossover Single Ascending Oral Dose Escalation Study to Assess the Safety Tolerability and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject
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 double-blind single dose four-period crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safetytolerability of single doses of GSK1605786A Approximately 24 subjects will receive three treatments of 250 500 and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg 500mg and 1000 mg under fasted conditions will be assessed In addition a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions
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