Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478738
Status:
COMPLETED
Last Update Posted:
2017-02-02
First Post:
2007-05-24
Brief Title:
A 2 Part Study Examining Doses Of GSK961081 In Healthy Volunteers And Then In COPD Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Study to Assess the Pharmacokinetics of Single Escalating Doses of Inhaled GSK961081 DPI a Dual Pharmacophore in Healthy Subjects Part 1 and a Randomised Double-blind Double Dummy Crossover Incomplete Block Study to Assess the Safety Tolerability Pharmacodynamics Pulmonary and Systemic and Pharmacokinetics of 14 Days Dosing With Inhaled GSK961081 DPI Compared With Placebo and Tiotropium Plus Salmeterol in Patients With COPD Part 2
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:
GSK961081 has previously been administered to healthy subjects in a nebulised formulation and the first part of this study which will be conducted in healthy subjects proposes to bridge the change from nebulised to DPI formulation of GSK961081 before administration to patients The second part of the study will be conducted in COPD patients and aims to assess the safety and bronchodilator profile of GSK961081 over 24 hours during 14 days dosing
Detailed Description:
A study to assess the pharmacokinetics of single escalating doses of inhaled GSK961081 DPI a dual pharmacophore in healthy subjects Part 1 and a randomised double-blind double dummy crossover incomplete block study to assess the safety tolerability pharmacodynamics pulmonary and systemic and pharmacokinetics of 14 days dosing with inhaled GSK961081 DPI compared with placebo and tiotropium plus salmeterol in patients with COPD Part 2
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