Study to Assess the Safety and PK of GSK573719 and GSK573719/GW642444(VI) Combination in Healthy Subjects and Subjects With Severe Renal Impairment
NCT01571999 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2017-07-25
Summary
This study will assess the safety and pharmacokinetics of inhaled GSK573719 and GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal impairment. The results of the study will provide guidance on the use of this product in subjects with severe renal impairment.
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
Inhaled GSK573719
All subjects will receive a single dose of GSK573719 (125mcg) in treatment period 1
- DRUG
-
Inhaled GSK573719/vilanterol
All subjects will receive a single dose of GSK573719 (125mcg)/vilanterol (25mcg) in treatment period 2
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-03-29
- Primary Completion
- 2012-06-22
- Completion
- 2012-06-22
Countries
- Czechia
- Hungary
Study Locations
More Related Trials
-
28-day Repeat Dose Study of GSK573719
NCT01030965 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD
NCT01039675 ·Status: COMPLETED ·Phase: PHASE2
-
A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
NCT00803673 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
NCT00515502 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy Subjects.
NCT00671216 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
NCT01387230 ·Status: COMPLETED ·Phase: PHASE3
-
A 24-week Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD
NCT01636713 ·Status: COMPLETED ·Phase: PHASE3
-
QTc Study GSK573719+GW642444
NCT01521377 ·Status: COMPLETED ·Phase: PHASE1
-
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A
NCT01328444 ·Status: COMPLETED ·Phase: PHASE3
-
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
NCT00354042 ·Status: COMPLETED ·Phase: PHASE1
-
A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
NCT01313637 ·Status: COMPLETED ·Phase: PHASE3
-
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
NCT00950807 ·Status: COMPLETED ·Phase: PHASE2
-
A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD
NCT01313650 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy Subjects
NCT00783003 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects
NCT00625196 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Safety Study for GSK573719/GW642444 in Japanese
NCT01376388 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
NCT02040597 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Excretion Balance and Pharmacokinetics of 14C-GSK573719
NCT01362257 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
NCT00538057 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT05677347 ·Status: COMPLETED ·Phase: PHASE1
-
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B
NCT01323660 ·Status: COMPLETED ·Phase: PHASE3
-
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
NCT00376714 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Effects of Repeat Doses of Fluticasone Furoate and GW642444M Combination in Healthy Subjects and in Subjects With Severe Impairment.
NCT01266980 ·Status: COMPLETED ·Phase: PHASE1
-
Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
NCT00500461 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of RV1729
NCT01813084 ·Status: COMPLETED ·Phase: PHASE1