GSK Investigational Site
Harrow, Middlesex, HA1 3UJ, United Kingdom
NCT Number: NCT00555022
GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD)
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Harrow, Middlesex, HA1 3UJ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The subject has taken:
GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.
Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.
Subjects will receive placebo.
Time frame: Up to Week 24
An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time frame: Up to Week 24
Systolic and diastolic blood pressure will be measured in a semi-recumbent position after 5 minutes rest.
Time frame: Up to Week 24
Heart rate will be measured in a semi-recumbent position after 5 minutes rest.
Time frame: Up to Week 24
Triplicate 12-lead ECGs will be measured in a semi-recumbent position after 5 minutes rest at each time point using ECG machine.
Time frame: Up to 24 hour
Holter monitoring will be conducted at 24 hour.
Time frame: Up to Week 24
Lung function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second.
Time frame: Up to Week 24
Lung function will be measured by FVC, defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time frame: Up to Week 24
Hematology parameters will be assessed as a measure of safety.
Time frame: Up to Week 24
Clinical parameters will be assessed as a measure of safety.
Time frame: Up to Week 24
Urinalysis will be performed as a measure of safety.
Time frame: Up to 4 hours
Maximum value for heart rate over 0-4 hour will be determined.
Time frame: Up to 4 hours
Maximum value for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Time frame: Up to 4 hours
Maximum value for resting ECG over 0-4 hour will be determined.
Time frame: Up to 4 hours
Weighted mean for resting heart rate over 0-4 hour will be determined.
Time frame: Up to 4 hours
Weighted mean for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Time frame: Up to 4 hours
Weighted mean for resting resting ECG over 0-4 hour will be determined.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Plasma samples will be collected at the indicated time points to measure the concentration of GSK1160724.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Plasma samples will be collected at the indicated time points to measure the concentration of the active metabolite GSK1762245.
Time frame: 0-2 hours, 2-8 hours, 8-12 hours and 12-24 hours
Urine samples will be collected at the indicated time points to measure the concentration of GSK1160724.
Time frame: 0-2 hours, 2-8 hours, 8-12 hours and 12-24 hours
Urine samples will be collected at the indicated time points to measure the concentration of the active metabolite GSK1762245.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time frame: Up to 24 hours
The sGaw response will be assessed by whole body plethysmograph at the indicated timepoints.
Time frame: Up to 24 hours
The sGaw response will be assessed by whole body plethysmograph at the indicated timepoints.
Time frame: Up to 24 hours
The sGaw response will be assessed by whole body plethysmograph at the indicated timepoints.
Time frame: Up to 48 hours
The sGaw is a measure of the change in specific airway conductance. It will be assessed by whole body plethysmograph at the indicated timepoints.
GlaxoSmithKline
Industry
A Randomized Double-blind, Placebo-controlled, Crossover, Dose Escalation Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK1160724 and Tiotropium Bromide
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07252908
Chronic Disease, Disease Attributes
Chongqing, Chognqing, China
View Trial DetailsNCT07649577
Asthma, Bronchial Diseases
Amman, Jordan
View Trial DetailsNCT06979518
Chronic Disease, Disease Attributes
Cypress, California, United States
View Trial DetailsNCT06367686
Apnea, Chronic Disease
Tønsberg, Norway
View Trial Details