Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-03 @ 11:48 PM
Study NCT ID:
NCT00424034
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2007-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GSK1325760A in Healthy Japanese Subjects
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Phase I Study of Ambrisentan - Single Dose Study in Healthy Japanese Male Subjects
Status:
COMPLETED
Status Verified Date:
2017-01
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:
To investigate the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics after single oral administrations of GSK1325760A
Detailed Description:
Phase1 study of GSK1325760A
\- A double blind, single center, randomised, placebo-controlled, partially crossover, single dose study to investigate the safety, tolerability, pharmacokinetics and to assess the effect of food on pharmacokinetics of ascending oral doses of GSK1325760A in healthy Japanese male subject -
\- A double blind, single center, randomised, placebo-controlled, partially crossover, single dose study to investigate the safety, tolerability, pharmacokinetics and to assess the effect of food on pharmacokinetics of ascending oral doses of GSK1325760A in healthy Japanese male subject -
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: