Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1160724 · 1 trial · 1 indication
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.
Systolic and diastolic blood pressure will be measured in a semi-recumbent position after 5 minutes rest.
Heart rate will be measured in a semi-recumbent position after 5 minutes rest.
Triplicate 12-lead ECGs will be measured in a semi-recumbent position after 5 minutes rest at each time point using ECG machine.
Holter monitoring will be conducted at 24 hour.
Lung function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second.
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.
Hematology parameters will be assessed as a measure of safety.
Clinical parameters will be assessed as a measure of safety.
Urinalysis will be performed as a measure of safety.
Maximum value for heart rate over 0-4 hour will be determined.
Maximum value for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Maximum value for resting ECG over 0-4 hour will be determined.
Weighted mean for resting heart rate over 0-4 hour will be determined.
Weighted mean for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Weighted mean for resting resting ECG over 0-4 hour will be determined.
| Arm | Type | Description |
|---|---|---|
| All subjects | EXPERIMENTAL | Eligible subjects will receive one of the following treatment in cohort I and cohort II in five different treatment periods; Placebo, GSK1160724 (10 micrograms, 50 micrograms or 125 micrograms) and tiotropium bromide |
| Name | Type | Description |
|---|---|---|
| GSK1160724 | DRUG | GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler. |
| Tiotropium bromide | DRUG | Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device. |
| Placebo | DRUG | Subjects will receive placebo. |
Inclusion Criteria: * Healthy male and female subjects. Female subjects must be of non-child bearing potential. * Aged between 18-55 years inclusive * Non-smokers * Normal spirometry * A signed and dated written informed consent is obtained from the subject * The subject is capable of giving inform...
GSK1160724 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is in Phase 1 clinical development and is not yet approved. The drug is being studied for its potential effect on pulmonary disease, specifically chronic obstructive pulmonary disease.
GSK1160724 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in respiratory disease.
GSK1160724 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for chronic obstructive pulmonary disease.
GSK1160724 has one completed Phase 1 clinical trial, NCT00555022, titled 'Effect of GSK1160724 In Healthy Volunteers'. This trial enrolled 21 participants in the United Kingdom and was an uncontrolled, randomized study. The trial was not double-blind and did not use a control group.
No, GSK1160724 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for chronic obstructive pulmonary disease. The Phase 1 trial has been completed, but the drug has not yet progressed to later-stage trials or received regulatory approval.