Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00555022 | Effect of GSK1160724 In Healthy Volunteers | PHASE1 | COMPLETED | 21 | — | — | Dec 12, 2007 | Apr 7, 2008 | Sep 8, 2017 | 1 | United Kingdom |
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...