Clinical Trials Logo
  1. Home
  2. Respiratory Disorders
  3. NCT01818024

A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

Respiratory Disorders Clinical Trial

Official title:
A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

Clinical Trial Summary

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.

Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.

Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.

Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01818024
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date February 22, 2013
Completion date October 25, 2013
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT00844935 - Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients N/A
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Completed NCT01395849 - Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol) N/A
Completed NCT03557645 - Ventilator Hyperinflation and Hemodynamics N/A
Completed NCT03281876 - A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response. Phase 2
Completed NCT01395862 - Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol) N/A
Completed NCT01476046 - Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects. Phase 1
Completed NCT01587807 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057 Phase 1
Completed NCT00835003 - Timing of Planned Caesarean Section and Morbidity of the Newborn N/A
Completed NCT03443427 - A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine Phase 2
Completed NCT01360398 - Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly N/A
Completed NCT03201211 - A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults Phase 1
Completed NCT02075541 - A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction. Phase 2
Completed NCT00455767 - Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients Phase 2
Withdrawn NCT01505556 - Proprioceptive Postural Control and Diaphragm Paresis
Completed NCT01505582 - Inspiratory Muscle Training and Low Back Pain N/A
Completed NCT02322671 - Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects Phase 1
Recruiting NCT02316379 - Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration Phase 1/Phase 2
Completed NCT01516437 - A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD N/A
Recruiting NCT02272049 - Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults Phase 1/Phase 2