Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475436
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-05-16
Brief Title:
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single-centre Randomised Double-blind Placebo-controlled Dose-ascending 3-cohort Parallel-group Study to Evaluate the Safety Tolerability Pharmacodynamics and Pharmacokinetics of GSK573719 Administered as Singledoses 750 μg and 1000 μg and Repeat Doses Over 14 Days 250 μg-1000 μg Once-daily of GSK573719 in Healthy Male and Female Subjects
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:
GSK573719 is a high-affinity specific muscarinic receptor mAChR antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease COPD The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD
Detailed Description:
A single-centre randomised double-blind placebo-controlled dose-ascending 3-cohort parallel-group study to evaluate the safety tolerability pharmacodynamics and pharmacokinetics of GSK573719 administered as single doses 750µg and 1000µg and repeat doses over 14 days 250µg-1000µg once-daily of GSK573719 in healthy male and female subjects
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