Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
pharmacodynamics,, Chronic Obstructive Pulmonary Disease (COPD), safety,, COPD patients, pharmacokinetics,, tolerability,, GW642444,
Brief summary
This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared in the form of a salt, and inactive ingredients (excipients) are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the 'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt form of the study drug has been prepared with lactose and a new excipient called magnesium stearate (instead of cellobiose octaacetate). Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This study will be the first time the new 'M' salt form of the study drug will be given to COPD patients.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female (of non-childbearing potential) \> or = 40 years * History of COPD * Smoker or ex-smoker * Body weight \> or = 50 kg with BMI 18-32 kg/m2
Exclusion criteria
* History of significant disease * Subjects with a primary asthma diagnosis * Alpha-1 antitrypsin deficiency as underlying cause of COPD * Recent respiratory tract infection * Poorly controlled COPD * Blood potassium level \< 3.5mmol/L * Short-term or long tern oxygen therapy * Recent participation in another trial * History of drug or alcohol abuse * Known allergies * Recent blood donation * ECG abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | ECG parameters \[PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals\] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | From the first dose of the study medication until the Follow-up Visit (up to Study Day 60) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
| Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Baseline and Day 1 of each treatment period (up to Study Day 54) | QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F). |
| Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | Baseline and Day 1 of each treatment period (up to Study Day 54) | Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate. |
| Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP. |
| Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter \[mL\]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium. |
| AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | Baseline and Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined. |
| Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined. |
| Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | Day 1 of each treatment period (up to Study Day 54) | Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined. |
| Mean FEV1 Over 23 and 24 Hours After Dosing | Baseline and Day 1 of each treatment period (up to Study Day 54) | Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects . |
Countries
Germany
Participant flow
Pre-assignment details
Participants meeting eligibility criteria at screening were randomized and entered a treatment period. Participants were then randomized to 4 treatment periods in one of 16 sequences (seq) each lasting 1 day and separated by a 7 - 14 day washout period.
Participants by arm
| Arm | Count |
|---|---|
| GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning). | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 2 | Unable Evaluate Cardiovascular Endpoints | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 4 | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq |
|---|---|
| Age, Continuous | 62.3 Years STANDARD_DEVIATION 7.57 |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 20 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 19 | 1 / 20 | 2 / 19 | 0 / 8 | 0 / 12 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 | 0 / 19 | 0 / 8 | 0 / 12 |
Outcome results
Primary
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | GGT, n=17, 15, 17, 7, 10 | -2.0 International units per liter (IU/L) | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALT, n=17, 15, 17, 7, 10 | 0.1 International units per liter (IU/L) | Standard Deviation 3.89 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | CK n=17, 15, 17, 7, 10 | -18.1 International units per liter (IU/L) | Standard Deviation 29.9 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALP, n=17, 15, 17, 7, 10 | 0.4 International units per liter (IU/L) | Standard Deviation 10.05 |
| Placebo | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | AST, n=17, 13, 17, 6, 9 | -0.1 International units per liter (IU/L) | Standard Deviation 5.46 |
| GW642444M 25 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | GGT, n=17, 15, 17, 7, 10 | -0.9 International units per liter (IU/L) | Standard Deviation 3.99 |
| GW642444M 25 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | AST, n=17, 13, 17, 6, 9 | -0.6 International units per liter (IU/L) | Standard Deviation 2.87 |
| GW642444M 25 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALP, n=17, 15, 17, 7, 10 | 1.6 International units per liter (IU/L) | Standard Deviation 4.9 |
| GW642444M 25 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | CK n=17, 15, 17, 7, 10 | -20.5 International units per liter (IU/L) | Standard Deviation 36.07 |
| GW642444M 25 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALT, n=17, 15, 17, 7, 10 | -0.5 International units per liter (IU/L) | Standard Deviation 2 |
| GW642444M 50 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | AST, n=17, 13, 17, 6, 9 | -1.6 International units per liter (IU/L) | Standard Deviation 2.69 |
| GW642444M 50 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALT, n=17, 15, 17, 7, 10 | 1.1 International units per liter (IU/L) | Standard Deviation 2.75 |
| GW642444M 50 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALP, n=17, 15, 17, 7, 10 | 0.6 International units per liter (IU/L) | Standard Deviation 5.93 |
| GW642444M 50 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | GGT, n=17, 15, 17, 7, 10 | -0.5 International units per liter (IU/L) | Standard Deviation 5.06 |
| GW642444M 50 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | CK n=17, 15, 17, 7, 10 | -38.1 International units per liter (IU/L) | Standard Deviation 69.67 |
| GW642444M 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | CK n=17, 15, 17, 7, 10 | -3.1 International units per liter (IU/L) | Standard Deviation 15.99 |
| GW642444M 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALT, n=17, 15, 17, 7, 10 | -0.6 International units per liter (IU/L) | Standard Deviation 1.51 |
| GW642444M 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | GGT, n=17, 15, 17, 7, 10 | -1.6 International units per liter (IU/L) | Standard Deviation 2.88 |
| GW642444M 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | AST, n=17, 13, 17, 6, 9 | -1.7 International units per liter (IU/L) | Standard Deviation 1.03 |
| GW642444M 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALP, n=17, 15, 17, 7, 10 | -0.4 International units per liter (IU/L) | Standard Deviation 2.37 |
| GW642444H 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | AST, n=17, 13, 17, 6, 9 | 2.1 International units per liter (IU/L) | Standard Deviation 5.84 |
| GW642444H 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | GGT, n=17, 15, 17, 7, 10 | 0.5 International units per liter (IU/L) | Standard Deviation 5.21 |
| GW642444H 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALT, n=17, 15, 17, 7, 10 | 1.0 International units per liter (IU/L) | Standard Deviation 4.08 |
| GW642444H 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | CK n=17, 15, 17, 7, 10 | -19.9 International units per liter (IU/L) | Standard Deviation 20.89 |
| GW642444H 100 µg | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | ALP, n=17, 15, 17, 7, 10 | 1.2 International units per liter (IU/L) | Standard Deviation 6.91 |
Primary
Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of albumin and total protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Albumin, n=17, 15, 17, 7, 10 | -0.9 Grams per liter | Standard Deviation 2.3 |
| Placebo | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total protein, n=17, 15, 17, 7, 10 | -1.7 Grams per liter | Standard Deviation 4.22 |
| GW642444M 25 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Albumin, n=17, 15, 17, 7, 10 | -0.1 Grams per liter | Standard Deviation 1.85 |
| GW642444M 25 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total protein, n=17, 15, 17, 7, 10 | -0.5 Grams per liter | Standard Deviation 2.59 |
| GW642444M 50 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Albumin, n=17, 15, 17, 7, 10 | -0.2 Grams per liter | Standard Deviation 1.51 |
| GW642444M 50 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total protein, n=17, 15, 17, 7, 10 | 0.1 Grams per liter | Standard Deviation 2.34 |
| GW642444M 100 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total protein, n=17, 15, 17, 7, 10 | -0.7 Grams per liter | Standard Deviation 3.4 |
| GW642444M 100 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Albumin, n=17, 15, 17, 7, 10 | -0.9 Grams per liter | Standard Deviation 1.95 |
| GW642444H 100 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Albumin, n=17, 15, 17, 7, 10 | 0.1 Grams per liter | Standard Deviation 0.88 |
| GW642444H 100 µg | Change From Baseline in Albumin and Total Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total protein, n=17, 15, 17, 7, 10 | 0.8 Grams per liter | Standard Deviation 1.55 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and white blood cell (WBC) count at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Basophils, n=19, 20, 19, 8, 11 | 0.004 10^9 cells per liter (GI/L) | Standard Deviation 0.0154 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | WBC, n=19, 20, 19, 8, 11 | -0.02 10^9 cells per liter (GI/L) | Standard Deviation 0.807 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Platelet count, n=19, 20, 19, 8, 11 | 5.0 10^9 cells per liter (GI/L) | Standard Deviation 16.16 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Lymphocytes, n=19, 20, 19, 8, 11 | 0.068 10^9 cells per liter (GI/L) | Standard Deviation 0.4094 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Eosinophils, n=19, 20, 19, 8, 11 | 0.003 10^9 cells per liter (GI/L) | Standard Deviation 0.1771 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Monocytes, n=19, 20, 19, 8, 11 | 0.006 10^9 cells per liter (GI/L) | Standard Deviation 0.1323 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Neutrophils, n=19, 20, 19, 8, 11 | -0.100 10^9 cells per liter (GI/L) | Standard Deviation 0.6174 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Neutrophils, n=19, 20, 19, 8, 11 | 0.188 10^9 cells per liter (GI/L) | Standard Deviation 0.9814 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Monocytes, n=19, 20, 19, 8, 11 | -0.027 10^9 cells per liter (GI/L) | Standard Deviation 0.139 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Eosinophils, n=19, 20, 19, 8, 11 | -0.045 10^9 cells per liter (GI/L) | Standard Deviation 0.0707 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Basophils, n=19, 20, 19, 8, 11 | 0.001 10^9 cells per liter (GI/L) | Standard Deviation 0.0168 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Platelet count, n=19, 20, 19, 8, 11 | 8.2 10^9 cells per liter (GI/L) | Standard Deviation 18.38 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Lymphocytes, n=19, 20, 19, 8, 11 | 0.021 10^9 cells per liter (GI/L) | Standard Deviation 0.3719 |
| GW642444M 25 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | WBC, n=19, 20, 19, 8, 11 | 0.14 10^9 cells per liter (GI/L) | Standard Deviation 1.215 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Monocytes, n=19, 20, 19, 8, 11 | 0.007 10^9 cells per liter (GI/L) | Standard Deviation 0.0917 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Basophils, n=19, 20, 19, 8, 11 | 0.001 10^9 cells per liter (GI/L) | Standard Deviation 0.0133 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Eosinophils, n=19, 20, 19, 8, 11 | -0.023 10^9 cells per liter (GI/L) | Standard Deviation 0.0921 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Lymphocytes, n=19, 20, 19, 8, 11 | -0.126 10^9 cells per liter (GI/L) | Standard Deviation 0.2608 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Neutrophils, n=19, 20, 19, 8, 11 | 0.343 10^9 cells per liter (GI/L) | Standard Deviation 0.9674 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Platelet count, n=19, 20, 19, 8, 11 | 8.5 10^9 cells per liter (GI/L) | Standard Deviation 15.33 |
| GW642444M 50 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | WBC, n=19, 20, 19, 8, 11 | 0.20 10^9 cells per liter (GI/L) | Standard Deviation 1.029 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Lymphocytes, n=19, 20, 19, 8, 11 | -0.146 10^9 cells per liter (GI/L) | Standard Deviation 0.4055 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Neutrophils, n=19, 20, 19, 8, 11 | 0.201 10^9 cells per liter (GI/L) | Standard Deviation 0.6165 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Eosinophils, n=19, 20, 19, 8, 11 | -0.031 10^9 cells per liter (GI/L) | Standard Deviation 0.0895 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | WBC, n=19, 20, 19, 8, 11 | 0.04 10^9 cells per liter (GI/L) | Standard Deviation 1.094 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Platelet count, n=19, 20, 19, 8, 11 | 9.5 10^9 cells per liter (GI/L) | Standard Deviation 13.72 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Basophils, n=19, 20, 19, 8, 11 | 0.004 10^9 cells per liter (GI/L) | Standard Deviation 0.0185 |
| GW642444M 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Monocytes, n=19, 20, 19, 8, 11 | -0.018 10^9 cells per liter (GI/L) | Standard Deviation 0.1331 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Lymphocytes, n=19, 20, 19, 8, 11 | -0.116 10^9 cells per liter (GI/L) | Standard Deviation 0.3261 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | WBC, n=19, 20, 19, 8, 11 | -0.12 10^9 cells per liter (GI/L) | Standard Deviation 0.774 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Platelet count, n=19, 20, 19, 8, 11 | -1.1 10^9 cells per liter (GI/L) | Standard Deviation 10.82 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Neutrophils, n=19, 20, 19, 8, 11 | -0.021 10^9 cells per liter (GI/L) | Standard Deviation 0.7415 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Eosinophils, n=19, 20, 19, 8, 11 | -0.002 10^9 cells per liter (GI/L) | Standard Deviation 0.0637 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Basophils, n=19, 20, 19, 8, 11 | -0.004 10^9 cells per liter (GI/L) | Standard Deviation 0.0211 |
| GW642444H 100 µg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Monocytes, n=19, 20, 19, 8, 11 | 0.025 10^9 cells per liter (GI/L) | Standard Deviation 0.1347 |
Primary
Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of cholesterol, chloride, potassium, sodium, triglycerides, and urea at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Cholesterol, n=17, 15, 17, 7, 10 | -0.085 Millimoles per liter (mmol/L) | Standard Deviation 0.3416 |
| Placebo | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Chloride, n=17, 15, 17, 7, 10 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.65 |
| Placebo | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Potassium, n=17, 13, 17, 6, 9 | 0.12 Millimoles per liter (mmol/L) | Standard Deviation 0.263 |
| Placebo | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Sodium, n=17, 15, 17, 7, 10 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.03 |
| Placebo | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Triglyceride, n=17, 15, 17, 7, 10 | -0.106 Millimoles per liter (mmol/L) | Standard Deviation 0.4625 |
| Placebo | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Urea, n=17, 15, 17, 7, 10 | 0.29 Millimoles per liter (mmol/L) | Standard Deviation 1.092 |
| GW642444M 25 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Triglyceride, n=17, 15, 17, 7, 10 | 0.024 Millimoles per liter (mmol/L) | Standard Deviation 0.5789 |
| GW642444M 25 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Urea, n=17, 15, 17, 7, 10 | -0.17 Millimoles per liter (mmol/L) | Standard Deviation 0.964 |
| GW642444M 25 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Cholesterol, n=17, 15, 17, 7, 10 | 0.121 Millimoles per liter (mmol/L) | Standard Deviation 0.3764 |
| GW642444M 25 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Potassium, n=17, 13, 17, 6, 9 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 0.384 |
| GW642444M 25 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Sodium, n=17, 15, 17, 7, 10 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.83 |
| GW642444M 25 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Chloride, n=17, 15, 17, 7, 10 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| GW642444M 50 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Sodium, n=17, 15, 17, 7, 10 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 1.41 |
| GW642444M 50 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Triglyceride, n=17, 15, 17, 7, 10 | -0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.38 |
| GW642444M 50 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Cholesterol, n=17, 15, 17, 7, 10 | 0.032 Millimoles per liter (mmol/L) | Standard Deviation 1.2588 |
| GW642444M 50 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Potassium, n=17, 13, 17, 6, 9 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.374 |
| GW642444M 50 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Chloride, n=17, 15, 17, 7, 10 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| GW642444M 50 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Urea, n=17, 15, 17, 7, 10 | -0.38 Millimoles per liter (mmol/L) | Standard Deviation 1.109 |
| GW642444M 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Sodium, n=17, 15, 17, 7, 10 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 1.15 |
| GW642444M 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Chloride, n=17, 15, 17, 7, 10 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 1.7 |
| GW642444M 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Potassium, n=17, 13, 17, 6, 9 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.358 |
| GW642444M 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Urea, n=17, 15, 17, 7, 10 | -0.17 Millimoles per liter (mmol/L) | Standard Deviation 0.427 |
| GW642444M 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Triglyceride, n=17, 15, 17, 7, 10 | -0.300 Millimoles per liter (mmol/L) | Standard Deviation 0.5812 |
| GW642444M 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Cholesterol, n=17, 15, 17, 7, 10 | -0.251 Millimoles per liter (mmol/L) | Standard Deviation 0.563 |
| GW642444H 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Triglyceride, n=17, 15, 17, 7, 10 | 0.142 Millimoles per liter (mmol/L) | Standard Deviation 0.2629 |
| GW642444H 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Potassium, n=17, 13, 17, 6, 9 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 0.305 |
| GW642444H 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Chloride, n=17, 15, 17, 7, 10 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 1.43 |
| GW642444H 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Urea, n=17, 15, 17, 7, 10 | 0.20 Millimoles per liter (mmol/L) | Standard Deviation 0.918 |
| GW642444H 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Sodium, n=17, 15, 17, 7, 10 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 1.79 |
| GW642444H 100 µg | Change From Baseline in Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea at 24 Hours Post-dose on Day 1 of Each Treatment Period | Cholesterol, n=17, 15, 17, 7, 10 | 0.082 Millimoles per liter (mmol/L) | Standard Deviation 0.2447 |
Primary
Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of c-reactive protein at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | -1.36 Milligrams per liter (Mg/L) | Standard Deviation 3.837 |
| GW642444M 25 µg | Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | 0.20 Milligrams per liter (Mg/L) | Standard Deviation 1.015 |
| GW642444M 50 µg | Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.47 Milligrams per liter (Mg/L) | Standard Deviation 3.5 |
| GW642444M 100 µg | Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.76 Milligrams per liter (Mg/L) | Standard Deviation 2.123 |
| GW642444H 100 µg | Change From Baseline in C-reactive Protein at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.93 Milligrams per liter (Mg/L) | Standard Deviation 2.965 |
Primary
Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period
ECG parameters \[PR, QRS, RR, QT (uncorrected), QTcB (QT corrected by Bazett's formula) and QTcF (QT corrected by Fridericia's formula) intervals\] were measured at Baseline and over the post-dose 24h period at the following scheduled time points: 20 minutes (min), 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline was defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: PP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PP Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 3 h, n=19, 19, 19, 8, 11 | 0.3 milliseconds (msec) | Standard Deviation 6.324 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 45 min, n=19, 19, 19, 8, 10 | -2.7 milliseconds (msec) | Standard Deviation 7.846 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 1 h, n=19, 19, 19, 8, 11 | -2.8 milliseconds (msec) | Standard Deviation 17.926 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 2 h, n=19, 19, 19, 8, 11 | -3.3 milliseconds (msec) | Standard Deviation 12.978 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 3 h, n=19, 19, 19, 8, 11 | 0.1 milliseconds (msec) | Standard Deviation 12.837 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 4 h, n=19, 19, 19, 8, 11 | -3.0 milliseconds (msec) | Standard Deviation 13.613 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 6 h, n=18, 19, 19, 8, 11 | -4.0 milliseconds (msec) | Standard Deviation 10.157 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 24 h, n=19, 19, 18, 8, 11 | -1.4 milliseconds (msec) | Standard Deviation 18.636 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 20 min, n=19, 19, 19, 8, 11 | -1.9 milliseconds (msec) | Standard Deviation 5.031 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 45 min, n=19, 19, 19, 8, 10 | -1.6 milliseconds (msec) | Standard Deviation 4.789 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 1 h, n=19, 19, 19, 8, 11 | -2.0 milliseconds (msec) | Standard Deviation 5.562 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 2 h, n=19, 19, 19, 8, 11 | 0.9 milliseconds (msec) | Standard Deviation 5.393 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 20 min, n=19, 19, 19, 8, 11 | -7.3 milliseconds (msec) | Standard Deviation 17.172 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 4 h, n=19, 19, 19, 8, 11 | -1.0 milliseconds (msec) | Standard Deviation 4.812 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 6 h, n=19, 19, 19, 8, 11 | -1.0 milliseconds (msec) | Standard Deviation 5.156 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 24 h, n=19, 19, 18, 8, 11 | -1.4 milliseconds (msec) | Standard Deviation 6.09 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 20 min, n=19, 19, 19, 8, 11 | 48.9 milliseconds (msec) | Standard Deviation 57.11 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 45 min, n=19, 19, 19, 8, 10 | 5.6 milliseconds (msec) | Standard Deviation 96.803 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 1 h, n=19, 19, 19, 8, 11 | 29.8 milliseconds (msec) | Standard Deviation 91.489 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 2 h, n=19, 19, 19, 8, 11 | -0.3 milliseconds (msec) | Standard Deviation 108.528 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 3 h, n=19, 19, 19, 8, 11 | -12.7 milliseconds (msec) | Standard Deviation 95.03 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 4 h, n=19, 19, 19, 8, 11 | -21.9 milliseconds (msec) | Standard Deviation 86.948 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 6 h, n=19, 19, 19, 8, 11 | -61.0 milliseconds (msec) | Standard Deviation 125.922 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 24 h, n=19, 19, 18, 8, 11 | -4.7 milliseconds (msec) | Standard Deviation 108.355 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 20 min, n=19, 19, 19, 8, 11 | 4.8 milliseconds (msec) | Standard Deviation 15.094 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 45 min, n=19, 19, 19, 8, 10 | 5.6 milliseconds (msec) | Standard Deviation 15.245 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 1 h, n=19, 19, 19, 8, 11 | 5.1 milliseconds (msec) | Standard Deviation 14.82 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 2 h, n=19, 19, 19, 8, 11 | -4.4 milliseconds (msec) | Standard Deviation 19.879 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 3 h, n=19, 19, 19, 8, 11 | -5.2 milliseconds (msec) | Standard Deviation 21.154 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 4 h, n=19, 19, 19, 8, 11 | -7.1 milliseconds (msec) | Standard Deviation 27.773 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 6 h, n=19, 19, 19, 8, 11 | -17.4 milliseconds (msec) | Standard Deviation 22.329 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 24 h, n=19, 19, 18, 8, 11 | -9.3 milliseconds (msec) | Standard Deviation 39.366 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 20 min, n=19, 19, 19, 8, 11 | -5.6 milliseconds (msec) | Standard Deviation 10.206 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 45 min, n=19, 19, 19, 8, 10 | 4.5 milliseconds (msec) | Standard Deviation 21.312 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 1 h, n=19, 19, 19, 8, 11 | -0.9 milliseconds (msec) | Standard Deviation 19.298 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 2 h, n=19, 19, 19, 8, 11 | -4.3 milliseconds (msec) | Standard Deviation 16.691 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 3 h, n=19, 19, 19, 8, 11 | -1.8 milliseconds (msec) | Standard Deviation 20.177 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 4 h, n=19, 19, 19, 8, 11 | -0.6 milliseconds (msec) | Standard Deviation 30.768 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 6 h, n=19, 19, 19, 8, 11 | -3.9 milliseconds (msec) | Standard Deviation 16.976 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 24 h, n=19, 19, 18, 8, 11 | -9.0 milliseconds (msec) | Standard Deviation 32.387 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 20 min, n=19, 19, 18, 8, 11 | -2.0 milliseconds (msec) | Standard Deviation 10.761 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 45 min, n=19, 19, 19, 8, 10 | 4.9 milliseconds (msec) | Standard Deviation 16.508 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 1 h, n=19, 19, 19, 8, 11 | 1.1 milliseconds (msec) | Standard Deviation 15.088 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 2 h, n=19, 19, 19, 8, 11 | -4.4 milliseconds (msec) | Standard Deviation 14.122 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 3 h, n=19, 19, 19, 8, 11 | -3.1 milliseconds (msec) | Standard Deviation 17.341 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 4 h, n=19, 19, 19, 8, 11 | -3.1 milliseconds (msec) | Standard Deviation 28.679 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 6 h, n=19, 19, 19, 8, 11 | -8.7 milliseconds (msec) | Standard Deviation 13.113 |
| Placebo | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 24 h, n=19, 19, 18, 8, 11 | -9.2 milliseconds (msec) | Standard Deviation 33.102 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 2 h, n=19, 19, 19, 8, 11 | -25.1 milliseconds (msec) | Standard Deviation 153.206 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 4 h, n=19, 19, 19, 8, 11 | -1.7 milliseconds (msec) | Standard Deviation 14.909 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 24 h, n=19, 19, 18, 8, 11 | -6.4 milliseconds (msec) | Standard Deviation 13.364 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 2 h, n=19, 19, 19, 8, 11 | -9.2 milliseconds (msec) | Standard Deviation 19.465 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 3 h, n=19, 19, 19, 8, 11 | -3.1 milliseconds (msec) | Standard Deviation 15.13 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 3 h, n=19, 19, 19, 8, 11 | -55.0 milliseconds (msec) | Standard Deviation 175.742 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 3 h, n=19, 19, 19, 8, 11 | 1.2 milliseconds (msec) | Standard Deviation 5.194 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 1 h, n=19, 19, 19, 8, 11 | 1.3 milliseconds (msec) | Standard Deviation 13.453 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 45 min, n=19, 19, 19, 8, 10 | -0.8 milliseconds (msec) | Standard Deviation 12.037 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 20 min, n=19, 19, 19, 8, 11 | -7.8 milliseconds (msec) | Standard Deviation 13.891 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 4 h, n=19, 19, 19, 8, 11 | -54.7 milliseconds (msec) | Standard Deviation 173.646 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 45 min, n=19, 19, 19, 8, 10 | 0.2 milliseconds (msec) | Standard Deviation 3.928 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 2 h, n=19, 19, 19, 8, 11 | -5.8 milliseconds (msec) | Standard Deviation 10.606 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 24 h, n=19, 19, 18, 8, 11 | 10.5 milliseconds (msec) | Standard Deviation 95.865 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 6 h, n=19, 19, 19, 8, 11 | -23.2 milliseconds (msec) | Standard Deviation 183.705 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 24 h, n=19, 19, 18, 8, 11 | -7.1 milliseconds (msec) | Standard Deviation 15.386 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 2 h, n=19, 19, 19, 8, 11 | -1.1 milliseconds (msec) | Standard Deviation 11.047 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 6 h, n=19, 19, 19, 8, 11 | -11.1 milliseconds (msec) | Standard Deviation 10.871 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 4 h, n=19, 19, 19, 8, 11 | -0.9 milliseconds (msec) | Standard Deviation 3.961 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 20 min, n=19, 19, 18, 8, 11 | -6.5 milliseconds (msec) | Standard Deviation 14.867 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 1 h, n=19, 19, 19, 8, 11 | -2.7 milliseconds (msec) | Standard Deviation 14.946 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 45 min, n=19, 19, 19, 8, 10 | -3.7 milliseconds (msec) | Standard Deviation 15.106 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 45 min, n=19, 19, 19, 8, 10 | -2.1 milliseconds (msec) | Standard Deviation 11.43 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 6 h, n=19, 19, 19, 8, 11 | -0.1 milliseconds (msec) | Standard Deviation 4.485 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 20 min, n=19, 19, 19, 8, 11 | -1.4 milliseconds (msec) | Standard Deviation 15.486 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 6 h, n=19, 19, 19, 8, 11 | -9.3 milliseconds (msec) | Standard Deviation 18.612 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 4 h, n=19, 19, 19, 8, 11 | -4.4 milliseconds (msec) | Standard Deviation 13.49 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 20 min, n=19, 19, 19, 8, 11 | -1.0 milliseconds (msec) | Standard Deviation 3.886 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 24 h, n=19, 19, 18, 8, 11 | -1.5 milliseconds (msec) | Standard Deviation 3.736 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 24 h, n=19, 19, 18, 8, 11 | -1.6 milliseconds (msec) | Standard Deviation 17.618 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 3 h, n=19, 19, 19, 8, 11 | 0.0 milliseconds (msec) | Standard Deviation 19.55 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 2 h, n=19, 19, 19, 8, 11 | -3.9 milliseconds (msec) | Standard Deviation 18.963 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 1 h, n=19, 19, 19, 8, 11 | -7.5 milliseconds (msec) | Standard Deviation 15.779 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 20 min, n=19, 19, 19, 8, 11 | -9.0 milliseconds (msec) | Standard Deviation 75.077 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 2 h, n=19, 19, 19, 8, 11 | -0.3 milliseconds (msec) | Standard Deviation 3.888 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 4 h, n=19, 19, 19, 8, 11 | -8.8 milliseconds (msec) | Standard Deviation 10.344 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 45 min, n=19, 19, 19, 8, 10 | -2.8 milliseconds (msec) | Standard Deviation 13.737 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 20 min, n=19, 19, 19, 8, 11 | -5.7 milliseconds (msec) | Standard Deviation 18.465 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 45 min, n=19, 19, 19, 8, 10 | 9.1 milliseconds (msec) | Standard Deviation 65.366 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 1 h, n=19, 19, 19, 8, 11 | -0.9 milliseconds (msec) | Standard Deviation 4.449 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 24 h, n=19, 19, 18, 8, 11 | -4.8 milliseconds (msec) | Standard Deviation 19.461 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 6 h, n=19, 19, 19, 8, 11 | -14.1 milliseconds (msec) | Standard Deviation 26.54 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 4 h, n=19, 19, 19, 8, 11 | -16.6 milliseconds (msec) | Standard Deviation 29.661 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 1 h, n=19, 19, 19, 8, 11 | 39.9 milliseconds (msec) | Standard Deviation 65.636 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 6 h, n=18, 19, 19, 8, 11 | 0.5 milliseconds (msec) | Standard Deviation 15.174 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 3 h, n=19, 19, 19, 8, 11 | -4.4 milliseconds (msec) | Standard Deviation 13.383 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 3 h, n=19, 19, 19, 8, 11 | -12.4 milliseconds (msec) | Standard Deviation 28.408 |
| GW642444M 25 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 1 h, n=19, 19, 19, 8, 11 | -4.4 milliseconds (msec) | Standard Deviation 13.387 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 6 h, n=19, 19, 19, 8, 11 | -0.0 milliseconds (msec) | Standard Deviation 5.145 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 20 min, n=19, 19, 18, 8, 11 | -2.2 milliseconds (msec) | Standard Deviation 9.227 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 1 h, n=19, 19, 19, 8, 11 | -0.2 milliseconds (msec) | Standard Deviation 2.155 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 2 h, n=19, 19, 19, 8, 11 | 0.7 milliseconds (msec) | Standard Deviation 4.579 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 3 h, n=19, 19, 19, 8, 11 | 0.3 milliseconds (msec) | Standard Deviation 3.045 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 4 h, n=19, 19, 19, 8, 11 | 1.0 milliseconds (msec) | Standard Deviation 4.937 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 45 min, n=19, 19, 19, 8, 10 | 0.6 milliseconds (msec) | Standard Deviation 9.92 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 24 h, n=19, 19, 18, 8, 11 | 0.7 milliseconds (msec) | Standard Deviation 2.923 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 20 min, n=19, 19, 19, 8, 11 | 3.9 milliseconds (msec) | Standard Deviation 73.786 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 45 min, n=19, 19, 19, 8, 10 | -5.7 milliseconds (msec) | Standard Deviation 81.079 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 1 h, n=19, 19, 19, 8, 11 | -3.7 milliseconds (msec) | Standard Deviation 84.143 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 2 h, n=19, 19, 19, 8, 11 | -24.2 milliseconds (msec) | Standard Deviation 127.159 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 1 h, n=19, 19, 19, 8, 11 | 1.0 milliseconds (msec) | Standard Deviation 9.193 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 3 h, n=19, 19, 19, 8, 11 | 5.6 milliseconds (msec) | Standard Deviation 129.79 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 4 h, n=19, 19, 19, 8, 11 | -24.6 milliseconds (msec) | Standard Deviation 85.316 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 6 h, n=19, 19, 19, 8, 11 | -64.1 milliseconds (msec) | Standard Deviation 127.976 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 24 h, n=19, 19, 18, 8, 11 | 6.0 milliseconds (msec) | Standard Deviation 103.94 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 20 min, n=19, 19, 19, 8, 11 | -1.7 milliseconds (msec) | Standard Deviation 9.306 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 2 h, n=19, 19, 19, 8, 11 | -2.0 milliseconds (msec) | Standard Deviation 11.272 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 45 min, n=19, 19, 19, 8, 10 | -0.1 milliseconds (msec) | Standard Deviation 11.856 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 1 h, n=19, 19, 19, 8, 11 | 0.5 milliseconds (msec) | Standard Deviation 13.096 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 2 h, n=19, 19, 19, 8, 11 | -5.6 milliseconds (msec) | Standard Deviation 18.786 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 3 h, n=19, 19, 19, 8, 11 | 0.8 milliseconds (msec) | Standard Deviation 18.469 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 4 h, n=19, 19, 19, 8, 11 | -6.3 milliseconds (msec) | Standard Deviation 14.699 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 3 h, n=19, 19, 19, 8, 11 | 0.5 milliseconds (msec) | Standard Deviation 14.498 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 6 h, n=19, 19, 19, 8, 11 | -16.9 milliseconds (msec) | Standard Deviation 20.348 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 24 h, n=19, 19, 18, 8, 11 | 1.1 milliseconds (msec) | Standard Deviation 30.186 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 20 min, n=19, 19, 19, 8, 11 | -2.5 milliseconds (msec) | Standard Deviation 13.058 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 24 h, n=19, 19, 18, 8, 11 | 0.0 milliseconds (msec) | Standard Deviation 17.882 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 45 min, n=19, 19, 19, 8, 10 | 0.9 milliseconds (msec) | Standard Deviation 13.972 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 1 h, n=19, 19, 19, 8, 11 | 1.2 milliseconds (msec) | Standard Deviation 12.743 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 4 h, n=19, 19, 19, 8, 11 | -3.0 milliseconds (msec) | Standard Deviation 9.373 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 2 h, n=19, 19, 19, 8, 11 | 0.0 milliseconds (msec) | Standard Deviation 16.015 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 3 h, n=19, 19, 19, 8, 11 | 0.4 milliseconds (msec) | Standard Deviation 20.161 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 4 h, n=19, 19, 19, 8, 11 | -1.3 milliseconds (msec) | Standard Deviation 11.909 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 6 h, n=19, 19, 19, 8, 11 | -2.9 milliseconds (msec) | Standard Deviation 15.326 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 20 min, n=19, 19, 19, 8, 11 | 1.0 milliseconds (msec) | Standard Deviation 8.65 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 45 min, n=19, 19, 19, 8, 10 | 1.3 milliseconds (msec) | Standard Deviation 13.588 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 1 h, n=19, 19, 19, 8, 11 | -1.7 milliseconds (msec) | Standard Deviation 9.511 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 2 h, n=19, 19, 19, 8, 11 | -0.1 milliseconds (msec) | Standard Deviation 13.8 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 3 h, n=19, 19, 19, 8, 11 | 1.5 milliseconds (msec) | Standard Deviation 10.602 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 24 h, n=19, 19, 18, 8, 11 | -0.2 milliseconds (msec) | Standard Deviation 14.676 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 4 h, n=19, 19, 19, 8, 11 | 1.5 milliseconds (msec) | Standard Deviation 11.102 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 6 h, n=18, 19, 19, 8, 11 | -2.1 milliseconds (msec) | Standard Deviation 9.437 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 24 h, n=19, 19, 18, 8, 11 | 0.4 milliseconds (msec) | Standard Deviation 9.101 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 6 h, n=19, 19, 19, 8, 11 | -7.8 milliseconds (msec) | Standard Deviation 10.278 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 20 min, n=19, 19, 19, 8, 11 | 0.6 milliseconds (msec) | Standard Deviation 2.15 |
| GW642444M 50 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 45 min, n=19, 19, 19, 8, 10 | 0.2 milliseconds (msec) | Standard Deviation 3.534 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 3 h, n=19, 19, 19, 8, 11 | -10.8 milliseconds (msec) | Standard Deviation 15.253 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 1 h, n=19, 19, 19, 8, 11 | -29.1 milliseconds (msec) | Standard Deviation 101.9 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 3 h, n=19, 19, 19, 8, 11 | 2.8 milliseconds (msec) | Standard Deviation 20.863 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 4 h, n=19, 19, 19, 8, 11 | -5.0 milliseconds (msec) | Standard Deviation 16.399 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 6 h, n=19, 19, 19, 8, 11 | -20.0 milliseconds (msec) | Standard Deviation 22.842 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 3 h, n=19, 19, 19, 8, 11 | -6.2 milliseconds (msec) | Standard Deviation 11.842 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 45 min, n=19, 19, 19, 8, 10 | -73.0 milliseconds (msec) | Standard Deviation 130.999 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 24 h, n=19, 19, 18, 8, 11 | -0.3 milliseconds (msec) | Standard Deviation 14.331 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 20 min, n=19, 19, 19, 8, 11 | 7.6 milliseconds (msec) | Standard Deviation 24.453 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 4 h, n=19, 19, 19, 8, 11 | 16.98 milliseconds (msec) | Standard Deviation 25.887 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 45 min, n=19, 19, 19, 8, 10 | 18.5 milliseconds (msec) | Standard Deviation 20.184 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 20 min, n=19, 19, 19, 8, 11 | -29.2 milliseconds (msec) | Standard Deviation 123.015 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 45 min, n=19, 19, 19, 8, 10 | 13.0 milliseconds (msec) | Standard Deviation 12.102 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 24 h, n=19, 19, 18, 8, 11 | 0.3 milliseconds (msec) | Standard Deviation 9.022 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 1 h, n=19, 19, 19, 8, 11 | 7.9 milliseconds (msec) | Standard Deviation 11.202 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 2 h, n=19, 19, 19, 8, 11 | 1.2 milliseconds (msec) | Standard Deviation 1.265 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 20 min, n=19, 19, 19, 8, 11 | 1.0 milliseconds (msec) | Standard Deviation 4.719 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 2 h, n=19, 19, 19, 8, 11 | -4.4 milliseconds (msec) | Standard Deviation 22.214 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 4 h, n=19, 19, 19, 8, 11 | -2.7 milliseconds (msec) | Standard Deviation 11.136 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 24 h, n=19, 19, 18, 8, 11 | -0.0 milliseconds (msec) | Standard Deviation 4.783 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 6 h, n=18, 19, 19, 8, 11 | 23.59 milliseconds (msec) | Standard Deviation 21.544 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 3 h, n=19, 19, 19, 8, 11 | -3.8 milliseconds (msec) | Standard Deviation 17.665 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 4 h, n=19, 19, 19, 8, 11 | -1.5 milliseconds (msec) | Standard Deviation 14.136 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 24 h, n=19, 19, 18, 8, 11 | 0.0 milliseconds (msec) | Standard Deviation 0 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 6 h, n=19, 19, 19, 8, 11 | 0.1 milliseconds (msec) | Standard Deviation 4.254 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 45 min, n=19, 19, 19, 8, 10 | 0.0 milliseconds (msec) | Standard Deviation 2.156 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 20 min, n=19, 19, 18, 8, 11 | 5.9 milliseconds (msec) | Standard Deviation 19.428 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 20 min, n=19, 19, 19, 8, 11 | 0.5 milliseconds (msec) | Standard Deviation 11.295 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 6 h, n=19, 19, 19, 8, 11 | 3.4 milliseconds (msec) | Standard Deviation 12.821 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 45 min, n=19, 19, 19, 8, 10 | -4.5 milliseconds (msec) | Standard Deviation 12.912 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 4 h, n=19, 19, 19, 8, 11 | 1.0 milliseconds (msec) | Standard Deviation 4.759 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 24 h, n=19, 19, 18, 8, 11 | 27.07 milliseconds (msec) | Standard Deviation 20.769 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 1 h, n=19, 19, 19, 8, 11 | 4.3 milliseconds (msec) | Standard Deviation 19.07 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 6 h, n=19, 19, 19, 8, 11 | -4.7 milliseconds (msec) | Standard Deviation 5.959 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 6 h, n=19, 19, 19, 8, 11 | -106.1 milliseconds (msec) | Standard Deviation 160.044 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 24 h, n=19, 19, 18, 8, 11 | -1.6 milliseconds (msec) | Standard Deviation 76.068 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 4 h, n=19, 19, 19, 8, 11 | -17.9 milliseconds (msec) | Standard Deviation 97.684 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 1 h, n=19, 19, 19, 8, 11 | 6.2 milliseconds (msec) | Standard Deviation 8.626 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 20 min, n=19, 19, 19, 8, 11 | 2.2 milliseconds (msec) | Standard Deviation 18.15 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 2 h, n=19, 19, 19, 8, 11 | -10.1 milliseconds (msec) | Standard Deviation 44.279 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 45 min, n=19, 19, 19, 8, 10 | 2.1 milliseconds (msec) | Standard Deviation 8.75 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 2 h, n=19, 19, 19, 8, 11 | -6.5 milliseconds (msec) | Standard Deviation 16.576 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 3 h, n=19, 19, 19, 8, 11 | -35.7 milliseconds (msec) | Standard Deviation 112.038 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 3 h, n=19, 19, 19, 8, 11 | 0.9 milliseconds (msec) | Standard Deviation 1.389 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 1 h, n=19, 19, 19, 8, 11 | 2.6 milliseconds (msec) | Standard Deviation 14.876 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 2 h, n=19, 19, 19, 8, 11 | -10.5 milliseconds (msec) | Standard Deviation 15.296 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 2 h, n=19, 19, 19, 8, 11 | -29.3 milliseconds (msec) | Standard Deviation 105.815 |
| GW642444M 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 1 h, n=19, 19, 19, 8, 11 | 2.7 milliseconds (msec) | Standard Deviation 4.714 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 24 h, n=19, 19, 18, 8, 11 | 3.8 milliseconds (msec) | Standard Deviation 18.294 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 3 h, n=19, 19, 19, 8, 11 | -1.6 milliseconds (msec) | Standard Deviation 15.403 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 6 h, n=19, 19, 19, 8, 11 | -1.7 milliseconds (msec) | Standard Deviation 6.561 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 24 h, n=19, 19, 18, 8, 11 | 2.1 milliseconds (msec) | Standard Deviation 19.4 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 1 h, n=19, 19, 19, 8, 11 | -0.1 milliseconds (msec) | Standard Deviation 23.941 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 4 h, n=19, 19, 19, 8, 11 | -0.9 milliseconds (msec) | Standard Deviation 16.693 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 3 h, n=19, 19, 19, 8, 11 | -3.3 milliseconds (msec) | Standard Deviation 12.741 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 45 min, n=19, 19, 19, 8, 10 | 4.0 milliseconds (msec) | Standard Deviation 69.539 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 1 h, n=19, 19, 19, 8, 11 | 1.0 milliseconds (msec) | Standard Deviation 4.958 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 20 min, n=19, 19, 19, 8, 11 | -8.9 milliseconds (msec) | Standard Deviation 15.095 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 6 h, n=19, 19, 19, 8, 11 | -8.6 milliseconds (msec) | Standard Deviation 11.99 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 20 min, n=19, 19, 19, 8, 11 | -2.7 milliseconds (msec) | Standard Deviation 24.051 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 4 h, n=19, 19, 19, 8, 11 | 1.7 milliseconds (msec) | Standard Deviation 3.666 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 2 h, n=19, 19, 19, 8, 11 | -1.0 milliseconds (msec) | Standard Deviation 6.513 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 20 min, n=19, 19, 19, 8, 11 | 1.4 milliseconds (msec) | Standard Deviation 4.222 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 24 h, n=19, 19, 18, 8, 11 | -1.1 milliseconds (msec) | Standard Deviation 17.099 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 3 h, n=19, 19, 19, 8, 11 | -3.2 milliseconds (msec) | Standard Deviation 10.836 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 45 min, n=19, 19, 19, 8, 10 | -0.9 milliseconds (msec) | Standard Deviation 20.795 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 45 min, n=19, 19, 19, 8, 10 | 0.1 milliseconds (msec) | Standard Deviation 4.601 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 2 h, n=19, 19, 19, 8, 11 | 1.2 milliseconds (msec) | Standard Deviation 13.75 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 20 min, n=19, 19, 19, 8, 11 | -4.8 milliseconds (msec) | Standard Deviation 27.41 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 45 min, n=19, 19, 19, 8, 10 | -4.7 milliseconds (msec) | Standard Deviation 11.038 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 20 min, n=19, 19, 19, 8, 11 | 4.7 milliseconds (msec) | Standard Deviation 31.266 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 4 h, n=19, 19, 19, 8, 11 | -2.5 milliseconds (msec) | Standard Deviation 14.057 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 6 h, n=19, 19, 19, 8, 11 | 2.0 milliseconds (msec) | Standard Deviation 10.667 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 45 min, n=19, 19, 19, 8, 10 | -1.8 milliseconds (msec) | Standard Deviation 24.471 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 3 h, n=19, 19, 19, 8, 11 | 13.1 milliseconds (msec) | Standard Deviation 78.368 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 2 h, n=19, 19, 19, 8, 11 | 2.8 milliseconds (msec) | Standard Deviation 15.513 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 2 h, n=19, 19, 19, 8, 11 | -15.3 milliseconds (msec) | Standard Deviation 90.415 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 1 h, n=19, 19, 19, 8, 11 | -3.3 milliseconds (msec) | Standard Deviation 12.014 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 1 h, n=19, 19, 19, 8, 11 | -3.8 milliseconds (msec) | Standard Deviation 30.201 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 1 h, n=19, 19, 19, 8, 11 | -2.4 milliseconds (msec) | Standard Deviation 26.9 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 24 h, n=19, 19, 18, 8, 11 | -0.5 milliseconds (msec) | Standard Deviation 5.546 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 45 min, n=19, 19, 19, 8, 10 | 0.3 milliseconds (msec) | Standard Deviation 17.997 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 20 min, n=19, 19, 18, 8, 11 | -4.0 milliseconds (msec) | Standard Deviation 26.022 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 2 h, n=19, 19, 19, 8, 11 | 2.1 milliseconds (msec) | Standard Deviation 17.456 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 6 h, n=19, 19, 19, 8, 11 | -45.5 milliseconds (msec) | Standard Deviation 71.133 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 24 h, n=19, 19, 18, 8, 11 | 2.0 milliseconds (msec) | Standard Deviation 15.496 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 4 h, n=19, 19, 19, 8, 11 | 7.3 milliseconds (msec) | Standard Deviation 94.243 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 3 h, n=19, 19, 19, 8, 11 | 0.6 milliseconds (msec) | Standard Deviation 4.67 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 3 h, n=19, 19, 19, 8, 11 | -3.9 milliseconds (msec) | Standard Deviation 13.908 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(F), 4 h, n=19, 19, 19, 8, 11 | 10.836 milliseconds (msec) | Standard Deviation 8.648 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QRS, 6 h, n=19, 19, 19, 8, 11 | 2.0 milliseconds (msec) | Standard Deviation 4.177 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | PR, 6 h, n=18, 19, 19, 8, 11 | 3.5 milliseconds (msec) | Standard Deviation 11.536 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 1 h, n=19, 19, 19, 8, 11 | 11.3 milliseconds (msec) | Standard Deviation 66.621 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QTc(B), 4 h, n=19, 19, 19, 8, 11 | -1.6 milliseconds (msec) | Standard Deviation 11.578 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | RR, 24 h, n=19, 19, 18, 8, 11 | -18.8 milliseconds (msec) | Standard Deviation 81.88 |
| GW642444H 100 µg | Change From Baseline in Electrocardiographic (ECG) Parameters Over the Post-dose 24 Hour (h) Period | QT, 2 h, n=19, 19, 19, 8, 11 | -0.7 milliseconds (msec) | Standard Deviation 15.403 |
Primary
Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period
Heart rate (HR) was measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1 h, 2 h, 3 h, 4 h, 6 h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: Per Protocol (PP) Population: all participants included in the All Subjects population excluding a participant deemed not to have heart rate or other ECG parameters deemed suitable for evaluation. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 20 M, n=19, 19, 19, 8, 11 | -2.9 Beats per minute(bpm) | Standard Deviation 4.49 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 45 M, n=19, 19, 19, 8, 11 | 0.3 Beats per minute(bpm) | Standard Deviation 6.7 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 1 h, n=19, 19, 19, 8, 11 | -0.9 Beats per minute(bpm) | Standard Deviation 5.33 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 2 h, n=19, 19, 19, 8, 11 | 1.6 Beats per minute(bpm) | Standard Deviation 7.41 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 3 h, n=19, 19, 19, 8, 11 | 1.7 Beats per minute(bpm) | Standard Deviation 7.06 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 4 h, n=19, 19, 19, 8, 11 | 0.1 Beats per minute(bpm) | Standard Deviation 6.57 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 6 h, n=19, 19, 19, 8, 11 | 5.7 Beats per minute(bpm) | Standard Deviation 10.31 |
| Placebo | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 24 h, n=19, 19, 19, 8, 11 | 1.9 Beats per minute(bpm) | Standard Deviation 9.39 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 1 h, n=19, 19, 19, 8, 11 | -2.1 Beats per minute(bpm) | Standard Deviation 5.92 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 4 h, n=19, 19, 19, 8, 11 | 4.8 Beats per minute(bpm) | Standard Deviation 13.87 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 20 M, n=19, 19, 19, 8, 11 | 0.7 Beats per minute(bpm) | Standard Deviation 6.6 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 2 h, n=19, 19, 19, 8, 11 | 3.0 Beats per minute(bpm) | Standard Deviation 11.76 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 45 M, n=19, 19, 19, 8, 11 | -0.2 Beats per minute(bpm) | Standard Deviation 5.51 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 24 h, n=19, 19, 19, 8, 11 | 0.4 Beats per minute(bpm) | Standard Deviation 9.05 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 3 h, n=19, 19, 19, 8, 11 | 6.2 Beats per minute(bpm) | Standard Deviation 13.76 |
| GW642444M 25 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 6 h, n=19, 19, 19, 8, 11 | 2.1 Beats per minute(bpm) | Standard Deviation 14.37 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 6 h, n=19, 19, 19, 8, 11 | 6.0 Beats per minute(bpm) | Standard Deviation 9.32 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 24 h, n=19, 19, 19, 8, 11 | 0.2 Beats per minute(bpm) | Standard Deviation 6.19 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 2 h, n=19, 19, 19, 8, 11 | 3.3 Beats per minute(bpm) | Standard Deviation 8.34 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 4 h, n=19, 19, 19, 8, 11 | 2.0 Beats per minute(bpm) | Standard Deviation 6.4 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 1 h, n=19, 19, 19, 8, 11 | 0.7 Beats per minute(bpm) | Standard Deviation 6.74 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 45 M, n=19, 19, 19, 8, 11 | 0.3 Beats per minute(bpm) | Standard Deviation 5.49 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 20 M, n=19, 19, 19, 8, 11 | 0.1 Beats per minute(bpm) | Standard Deviation 5.58 |
| GW642444M 50 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 3 h, n=19, 19, 19, 8, 11 | 0.7 Beats per minute(bpm) | Standard Deviation 8.09 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 45 M, n=19, 19, 19, 8, 11 | 4.0 Beats per minute(bpm) | Standard Deviation 7.49 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 1 h, n=19, 19, 19, 8, 11 | 1.7 Beats per minute(bpm) | Standard Deviation 5.36 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 2 h, n=19, 19, 19, 8, 11 | 3.0 Beats per minute(bpm) | Standard Deviation 7 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 3 h, n=19, 19, 19, 8, 11 | 2.2 Beats per minute(bpm) | Standard Deviation 6.84 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 4 h, n=19, 19, 19, 8, 11 | 0.7 Beats per minute(bpm) | Standard Deviation 7.72 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 24 h, n=19, 19, 19, 8, 11 | 0.3 Beats per minute(bpm) | Standard Deviation 11.35 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 20 M, n=19, 19, 19, 8, 11 | 2.2 Beats per minute(bpm) | Standard Deviation 6.67 |
| GW642444M 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 6 h, n=19, 19, 19, 8, 11 | 7.4 Beats per minute(bpm) | Standard Deviation 11.35 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 2 h, n=19, 19, 19, 8, 11 | -0.1 Beats per minute(bpm) | Standard Deviation 7.46 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 24 h, n=19, 19, 19, 8, 11 | -0.2 Beats per minute(bpm) | Standard Deviation 7.91 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 1 h, n=19, 19, 19, 8, 11 | -2.2 Beats per minute(bpm) | Standard Deviation 5.59 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 6 h, n=19, 19, 19, 8, 11 | 3.6 Beats per minute(bpm) | Standard Deviation 8.4 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 20 M, n=19, 19, 19, 8, 11 | -2.4 Beats per minute(bpm) | Standard Deviation 3.62 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 4 h, n=19, 19, 19, 8, 11 | 0.1 Beats per minute(bpm) | Standard Deviation 6.1 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 45 M, n=19, 19, 19, 8, 11 | -1.9 Beats per minute(bpm) | Standard Deviation 6.7 |
| GW642444H 100 µg | Change From Baseline in Heart Rate Over the Post-dose 24 Hour (h) Period | 3 h, n=19, 19, 19, 8, 11 | 0.4 Beats per minute(bpm) | Standard Deviation 5.43 |
Primary
Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of hematocrit at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period | 0.0044 Proportion of 1.0 | Standard Deviation 0.02025 |
| GW642444M 25 µg | Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.0024 Proportion of 1.0 | Standard Deviation 0.02132 |
| GW642444M 50 µg | Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.0018 Proportion of 1.0 | Standard Deviation 0.01674 |
| GW642444M 100 µg | Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.0161 Proportion of 1.0 | Standard Deviation 0.01408 |
| GW642444H 100 µg | Change From Baseline in Hematocrit at 24 Hours Post-dose on Day 1 of Each Treatment Period | 0.0036 Proportion of 1.0 | Standard Deviation 0.02025 |
Primary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of hemoglobin and MCHC at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Hemoglobin, n=19, 20, 19, 8, 11 | -0.4 Grams per liter (g/L) | Standard Deviation 6.21 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | MCHC, n=19, 20, 19, 8, 11 | -3.5 Grams per liter (g/L) | Standard Deviation 5.23 |
| GW642444M 25 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Hemoglobin, n=19, 20, 19, 8, 11 | -1.2 Grams per liter (g/L) | Standard Deviation 6.41 |
| GW642444M 25 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | MCHC, n=19, 20, 19, 8, 11 | -5.8 Grams per liter (g/L) | Standard Deviation 22.66 |
| GW642444M 50 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Hemoglobin, n=19, 20, 19, 8, 11 | -0.5 Grams per liter (g/L) | Standard Deviation 4.02 |
| GW642444M 50 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | MCHC, n=19, 20, 19, 8, 11 | 1.7 Grams per liter (g/L) | Standard Deviation 5.58 |
| GW642444M 100 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | MCHC, n=19, 20, 19, 8, 11 | 5.3 Grams per liter (g/L) | Standard Deviation 3.65 |
| GW642444M 100 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Hemoglobin, n=19, 20, 19, 8, 11 | -3.0 Grams per liter (g/L) | Standard Deviation 4.21 |
| GW642444H 100 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | Hemoglobin, n=19, 20, 19, 8, 11 | 0.8 Grams per liter (g/L) | Standard Deviation 5.47 |
| GW642444H 100 µg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at 24 Hours Post-dose on Day 1 of Each Treatment Period | MCHC, n=19, 20, 19, 8, 11 | -0.8 Grams per liter (g/L) | Standard Deviation 6.27 |
Primary
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of MCH at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.11 10^12 picograms (pg) per cell | Standard Deviation 0.403 |
| GW642444M 25 µg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.22 10^12 picograms (pg) per cell | Standard Deviation 0.465 |
| GW642444M 50 µg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | 0.24 10^12 picograms (pg) per cell | Standard Deviation 0.581 |
| GW642444M 100 µg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | 0.14 10^12 picograms (pg) per cell | Standard Deviation 0.342 |
| GW642444H 100 µg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Values at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.21 10^12 picograms (pg) per cell | Standard Deviation 0.528 |
Primary
Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: Blood samples were collected for the measurement of MCV at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period | 0.6 10^15 femtoliters (fL) per cell | Standard Deviation 1.67 |
| GW642444M 25 µg | Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.2 10^15 femtoliters (fL) per cell | Standard Deviation 2.09 |
| GW642444M 50 µg | Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.2 10^15 femtoliters (fL) per cell | Standard Deviation 1.96 |
| GW642444M 100 µg | Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period | -1.0 10^15 femtoliters (fL) per cell | Standard Deviation 0.76 |
| GW642444H 100 µg | Change From Baseline in Mean Corpuscle Volume (MCV) at 24 Hours Post-dose on Day 1 of Each Treatment Period | -0.5 10^15 femtoliters (fL) per cell | Standard Deviation 1.81 |
Primary
Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of reticulocyte and RBCs at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | RBC, n=19, 20, 19, 8, 11 | 0.00 10^12 cells per liter (TI/L) | Standard Deviation 0.194 |
| Placebo | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Reticulocytes, n=19, 19, 19, 8, 11 | -0.00714 10^12 cells per liter (TI/L) | Standard Deviation 0.021416 |
| GW642444M 25 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | RBC, n=19, 20, 19, 8, 11 | 0.01 10^12 cells per liter (TI/L) | Standard Deviation 0.193 |
| GW642444M 25 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Reticulocytes, n=19, 19, 19, 8, 11 | -0.00065 10^12 cells per liter (TI/L) | Standard Deviation 0.019905 |
| GW642444M 50 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Reticulocytes, n=19, 19, 19, 8, 11 | 0.00208 10^12 cells per liter (TI/L) | Standard Deviation 0.017391 |
| GW642444M 50 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | RBC, n=19, 20, 19, 8, 11 | -0.01 10^12 cells per liter (TI/L) | Standard Deviation 0.137 |
| GW642444M 100 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Reticulocytes, n=19, 19, 19, 8, 11 | 0.00905 10^12 cells per liter (TI/L) | Standard Deviation 0.016387 |
| GW642444M 100 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | RBC, n=19, 20, 19, 8, 11 | -0.11 10^12 cells per liter (TI/L) | Standard Deviation 0.173 |
| GW642444H 100 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | RBC, n=19, 20, 19, 8, 11 | 0.05 10^12 cells per liter (TI/L) | Standard Deviation 0.186 |
| GW642444H 100 µg | Change From Baseline in Reticulocyte and Red Blood Cell (RBC) Count at 24 Hours Post-dose on Day 1 of Each Treatment Period | Reticulocytes, n=19, 19, 19, 8, 11 | 0.00094 10^12 cells per liter (TI/L) | Standard Deviation 0.012676 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period
SBP and DBP were measured at Baseline and over the post-dose 24 h period at the following scheduled time points: 20 minutes (M), 45 M, 1h, 2h, 3h, 4h, 6h, and 24 h. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 3 h, n=19, 19, 19, 8, 11 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 7.58 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 45 M, n=19, 19, 19, 8, 11 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 6.13 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 1 h, n=19, 19, 19, 8, 11 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 8.11 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 2 h, n=19, 19, 19, 8, 11 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 7.77 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 20 M, n=19, 19, 19, 8, 11 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 7.2 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 4 h, n=19, 19, 19, 8, 11 | 1.1 Millimeters of mercury (mmHg) | Standard Deviation 6.1 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 6 h, n=19, 19, 19, 8, 11 | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 9.41 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 24 h, n=19, 19, 19, 8, 11 | 0.4 Millimeters of mercury (mmHg) | Standard Deviation 7.53 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 20 M, n=19, 19, 19, 8, 11 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 4.17 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 45 M, n=19, 19, 19, 8, 11 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 4.65 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 1 h, n=19, 19, 19, 8, 11 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 7.12 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 2 h, n=19, 19, 19, 8, 11 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 6.65 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 3 h, n=19, 19, 19, 8, 11 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 7.32 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 4 h, n=19, 19, 19, 8, 11 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 5.05 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 6 h, n=19, 19, 19, 8, 11 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 7.03 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 24 h, n=19, 19, 19, 8, 11 | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 4.49 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 4 h, n=19, 19, 19, 8, 11 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 5.15 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 45 M, n=19, 19, 19, 8, 11 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 6.53 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 20 M, n=19, 19, 19, 8, 11 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 4.59 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 6 h, n=19, 19, 19, 8, 11 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 6.05 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 24 h, n=19, 19, 19, 8, 11 | 0.0 Millimeters of mercury (mmHg) | Standard Deviation 9.01 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 3 h, n=19, 19, 19, 8, 11 | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 9.75 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 2 h, n=19, 19, 19, 8, 11 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 9.23 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 45 M, n=19, 19, 19, 8, 11 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 9.16 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 20 M, n=19, 19, 19, 8, 11 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 6.01 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 3 h, n=19, 19, 19, 8, 11 | -0.0 Millimeters of mercury (mmHg) | Standard Deviation 5.94 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 4 h, n=19, 19, 19, 8, 11 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 9.99 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 1 h, n=19, 19, 19, 8, 11 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 5.83 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 24 h, n=19, 19, 19, 8, 11 | -0.5 Millimeters of mercury (mmHg) | Standard Deviation 5.62 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 2 h, n=19, 19, 19, 8, 11 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 7.21 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 1 h, n=19, 19, 19, 8, 11 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 4.46 |
| GW642444M 25 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 6 h, n=19, 19, 19, 8, 11 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 10.21 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 4 h, n=19, 19, 19, 8, 11 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 5.33 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 2 h, n=19, 19, 19, 8, 11 | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 11.16 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 3 h, n=19, 19, 19, 8, 11 | 2.6 Millimeters of mercury (mmHg) | Standard Deviation 7.92 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 4 h, n=19, 19, 19, 8, 11 | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 8.18 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 6 h, n=19, 19, 19, 8, 11 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 9.35 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 24 h, n=19, 19, 19, 8, 11 | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 8.7 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 6 h, n=19, 19, 19, 8, 11 | -2.9 Millimeters of mercury (mmHg) | Standard Deviation 5.05 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 20 M, n=19, 19, 19, 8, 11 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 3.95 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 45 M, n=19, 19, 19, 8, 11 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 5.91 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 1 h, n=19, 19, 19, 8, 11 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 4.81 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 2 h, n=19, 19, 19, 8, 11 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 5.73 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 3 h, n=19, 19, 19, 8, 11 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 5.62 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 20 M, n=19, 19, 19, 8, 11 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 4.59 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 24 h, n=19, 19, 19, 8, 11 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 6.88 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 45 M, n=19, 19, 19, 8, 11 | -2.6 Millimeters of mercury (mmHg) | Standard Deviation 8.34 |
| GW642444M 50 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 1 h, n=19, 19, 19, 8, 11 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 8.46 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 45 M, n=19, 19, 19, 8, 11 | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 6.63 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 24 h, n=19, 19, 19, 8, 11 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 5.38 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 1 h, n=19, 19, 19, 8, 11 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 9.03 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 4 h, n=19, 19, 19, 8, 11 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 5.08 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 2 h, n=19, 19, 19, 8, 11 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 6.35 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 4 h, n=19, 19, 19, 8, 11 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 7.59 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 3 h, n=19, 19, 19, 8, 11 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 5.1 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 2 h, n=19, 19, 19, 8, 11 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 7.73 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 20 M, n=19, 19, 19, 8, 11 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 5.38 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 1 h, n=19, 19, 19, 8, 11 | -3.1 Millimeters of mercury (mmHg) | Standard Deviation 10.2 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 24 h, n=19, 19, 19, 8, 11 | 3.5 Millimeters of mercury (mmHg) | Standard Deviation 9.1 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 3 h, n=19, 19, 19, 8, 11 | 4.7 Millimeters of mercury (mmHg) | Standard Deviation 8.68 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 20 M, n=19, 19, 19, 8, 11 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 1.93 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 6 h, n=19, 19, 19, 8, 11 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 5.61 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 6 h, n=19, 19, 19, 8, 11 | 3.9 Millimeters of mercury (mmHg) | Standard Deviation 9.82 |
| GW642444M 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 45 M, n=19, 19, 19, 8, 11 | 1.0 Millimeters of mercury (mmHg) | Standard Deviation 7.12 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 3 h, n=19, 19, 19, 8, 11 | -4.0 Millimeters of mercury (mmHg) | Standard Deviation 7.35 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 45 M, n=19, 19, 19, 8, 11 | -3.8 Millimeters of mercury (mmHg) | Standard Deviation 5.27 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 6 h, n=19, 19, 19, 8, 11 | -7.6 Millimeters of mercury (mmHg) | Standard Deviation 7.13 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 3 h, n=19, 19, 19, 8, 11 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 5.6 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 45 M, n=19, 19, 19, 8, 11 | -3.5 Millimeters of mercury (mmHg) | Standard Deviation 8.23 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 24 h, n=19, 19, 19, 8, 11 | -5.3 Millimeters of mercury (mmHg) | Standard Deviation 8.21 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 1 h, n=19, 19, 19, 8, 11 | -6.5 Millimeters of mercury (mmHg) | Standard Deviation 5.99 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 24 h, n=19, 19, 19, 8, 11 | -4.1 Millimeters of mercury (mmHg) | Standard Deviation 6.32 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 4 h, n=19, 19, 19, 8, 11 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 8.66 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 20 M, n=19, 19, 19, 8, 11 | -4.5 Millimeters of mercury (mmHg) | Standard Deviation 7.31 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 20 M, n=19, 19, 19, 8, 11 | -5.2 Millimeters of mercury (mmHg) | Standard Deviation 8.63 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 2 h, n=19, 19, 19, 8, 11 | -3.4 Millimeters of mercury (mmHg) | Standard Deviation 8.15 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 6 h, n=19, 19, 19, 8, 11 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 9.75 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | DBP, 4 h, n=19, 19, 19, 8, 11 | -4.7 Millimeters of mercury (mmHg) | Standard Deviation 7.76 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 2 h, n=19, 19, 19, 8, 11 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 6.43 |
| GW642444H 100 µg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over the Post-dose 24 Hour (h) Period | SBP, 1 h, n=19, 19, 19, 8, 11 | -4.8 Millimeters of mercury (mmHg) | Standard Deviation 5.29 |
Primary
Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period
Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline and 24 hours post-dose on Day 1of each treatment period. Baseline is defined as the measurement at Screening (Day -28 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Creatinine, n=17, 15, 17, 7, 10 | 3.5 Micromoles per liter (µmol/L) | Standard Deviation 5.96 |
| Placebo | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Bilirubin, n=17, 15, 17, 7, 10 | -1.1 Micromoles per liter (µmol/L) | Standard Deviation 2.33 |
| GW642444M 25 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Creatinine, n=17, 15, 17, 7, 10 | 4.9 Micromoles per liter (µmol/L) | Standard Deviation 5.62 |
| GW642444M 25 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Bilirubin, n=17, 15, 17, 7, 10 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 4.04 |
| GW642444M 50 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Creatinine, n=17, 15, 17, 7, 10 | 4.9 Micromoles per liter (µmol/L) | Standard Deviation 6.62 |
| GW642444M 50 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Bilirubin, n=17, 15, 17, 7, 10 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 3.6 |
| GW642444M 100 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Bilirubin, n=17, 15, 17, 7, 10 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 1.38 |
| GW642444M 100 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Creatinine, n=17, 15, 17, 7, 10 | 1.0 Micromoles per liter (µmol/L) | Standard Deviation 5.07 |
| GW642444H 100 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Creatinine, n=17, 15, 17, 7, 10 | 1.5 Micromoles per liter (µmol/L) | Standard Deviation 5.28 |
| GW642444H 100 µg | Change From Baseline in Total Bilirubin and Creatinine at 24 Hours Post-dose on Day 1 of Each Treatment Period | Total Bilirubin, n=17, 15, 17, 7, 10 | 1.0 Micromoles per liter (µmol/L) | Standard Deviation 3.92 |
Primary
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time frame: From the first dose of the study medication until the Follow-up Visit (up to Study Day 60)
Population: All Subjects Population: all participants who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 2 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| GW642444M 25 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 1 Participants |
| GW642444M 25 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| GW642444M 50 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 2 Participants |
| GW642444M 50 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| GW642444M 100 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
| GW642444M 100 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 0 Participants |
| GW642444H 100 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any AE | 0 Participants |
| GW642444H 100 µg | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | Any SAE | 0 Participants |
Secondary
AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009 using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. AUC defined as area under the plasma concentration curve from time zero to the last quantifiable concentration (AUC(0-t)), and up to 1 hour post-dose (AUC(0-1)) were determined by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: Pharmacokinetic (PK) Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GW642444M 25 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 25 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW64244, AUC(0-1), n=0, 11, 18, 8, 10 | 58.01 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 25.4 |
| GW642444M 25 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 25 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710, AUC (0-t), n=0, 0, 0, 1, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 25 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444, AUC(0-t), n=0, 17, 19, 8, 10 | 56.49 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 86.2 |
| GW642444M 50 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710, AUC (0-t), n=0, 0, 0, 1, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 50 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 50 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 50 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW64244, AUC(0-1), n=0, 11, 18, 8, 10 | 106.31 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 44.5 |
| GW642444M 50 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444, AUC(0-t), n=0, 17, 19, 8, 10 | 222.36 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 96.5 |
| GW642444M 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710, AUC (0-t), n=0, 0, 0, 1, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444, AUC(0-t), n=0, 17, 19, 8, 10 | 572.99 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 45.3 |
| GW642444M 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW64244, AUC(0-1), n=0, 11, 18, 8, 10 | 196.24 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 23.9 |
| GW642444M 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444M 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444H 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444H 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW64244, AUC(0-1), n=0, 11, 18, 8, 10 | 54.85 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 28.3 |
| GW642444H 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444, AUC(0-t), n=0, 17, 19, 8, 10 | 98.13 picograms.Hour/milliliter (pg.hr/mL) | Geometric Coefficient of Variation 0.782 |
| GW642444H 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710, AUC (0-t), n=0, 0, 0, 1, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
| GW642444H 100 µg | AUC(0- t) and up to 1 Hour Post-dose (AUC[0-1]) of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, AUC(0-t), n=0, 0, 0, 0, 0 | NA picograms.Hour/milliliter (pg.hr/mL) | — |
Secondary
Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The maximum observed plasma concentration (Cmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.
Time frame: Day 1 of each treatment period (up to Study Day 54)
Population: PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GW642444M 25 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 78.16 picograms/milliliter (pg/mL) | Geometric Coefficient of Variation 43.9 |
| GW642444M 25 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 25 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 25 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 50 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 50 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 50 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 50 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 150.60 picograms/milliliter (pg/mL) | Geometric Coefficient of Variation 53.1 |
| GW642444M 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444M 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 259.96 picograms/milliliter (pg/mL) | Geometric Coefficient of Variation 22.2 |
| GW642444H 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444H 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | NA picograms/milliliter (pg/mL) | — |
| GW642444H 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 73.70 picograms/milliliter (pg/mL) | Geometric Coefficient of Variation 35.7 |
| GW642444H 100 µg | Cmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA picograms/milliliter (pg/mL) | — |
Secondary
Mean FEV1 Over 23 and 24 Hours After Dosing
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. The data is presented as adjusted mean of the FEV1 values over 23 and 24 hours after dosing. Changed in trough FEV1 will be analysed using a model with baseline, treatment, period, as fixed effects .
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: PP Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean FEV1 Over 23 and 24 Hours After Dosing | 1.432 Liters | Standard Error 0.0402 |
| GW642444M 25 µg | Mean FEV1 Over 23 and 24 Hours After Dosing | 1.622 Liters | Standard Error 0.0431 |
| GW642444M 50 µg | Mean FEV1 Over 23 and 24 Hours After Dosing | 1.638 Liters | Standard Error 0.0415 |
| GW642444M 100 µg | Mean FEV1 Over 23 and 24 Hours After Dosing | 1.642 Liters | Standard Error 0.065 |
| GW642444H 100 µg | Mean FEV1 Over 23 and 24 Hours After Dosing | 1.569 Liters | Standard Error 0.0501 |
Secondary
Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444
Blood samples were collected pre-dose and at 2, 5, 10, 20, and 30 minutes, 1, 2, 4, 6, 8, 10, and 24 hour post-dose. Blood samples were analyzed for GW642444 and its metabolites GI179710, GW630200 and GSK932009, using a high performance liquid chromatography/mass spectrometry/mass (HPLC/MS/MS) spectrometry. The Time to maximum plasma concentration (Tmax) was determined from the concentration time data by non-compartmental methods. Assay censoring refers to some of the values being below the limit of quantification such that this parameter could not be defined.
Time frame: Day 1 of each treatment period (up to Study Day 54)
Population: PK Population: all participants who received at least one dose and for whom a PK sample was obtained and analyzed
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GW642444M 25 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 0.175 Hours |
| GW642444M 25 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | NA Hours |
| GW642444M 25 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444M 25 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444M 50 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | 0.140 Hours |
| GW642444M 50 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444M 50 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444M 50 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 0.200 Hours |
| GW642444M 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444M 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | 0.170 Hours |
| GW642444M 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444M 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 0.425 Hours |
| GW642444H 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GSK932009, n=0, 0, 0, 0, 0 | NA Hours |
| GW642444H 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GI179710,n=0, 0, 4, 7, 0 | NA Hours |
| GW642444H 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW642444,n=0, 20, 19, 8, 12 | 0.500 Hours |
| GW642444H 100 µg | Tmax of GW642444 and Its Metabolites GI179710, GW630200, and GSK932009, After a Single Dose of GW642444 | GW630200, n=0, 0, 0, 0, 0 | NA Hours |
Secondary
Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium
Blood samples were collected for the measurement of potassium and glucose at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3 and 4 hours post-dose on Day 1of the each treatment period. Whole blood samples (approximately 1.0 milliliter \[mL\]) was analysed for potassium and glucose using the i-STAT1 portable chemical analyser. The i-STAT1 system is an analyser designed for point of care testing and employs a hand-held chemistry analyzer and disposable cartridges, which in the configuration tested, are capable of measuring potassium, glucose, blood gases, electrolytes, metabolites and coagulation. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. The data is presented as adjusted mean of WM and maximum (max) glucose /minimum (min) potassium.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: PP Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Glucose, n=16,18,19,6,10 | 5.94 Millimoles per liter (mmol/L) | Standard Error 0.204 |
| Placebo | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Max Glucose, n=17, 20, 19, 6,10 | 6.73 Millimoles per liter (mmol/L) | Standard Error 0.342 |
| Placebo | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Potassium, n=15, 16, 17, 5,12 | 4.29 Millimoles per liter (mmol/L) | Standard Error 0.058 |
| Placebo | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Min Potassium, n=16, 20, 18, 6,12 | 4.02 Millimoles per liter (mmol/L) | Standard Error 0.052 |
| GW642444M 25 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Glucose, n=16,18,19,6,10 | 5.86 Millimoles per liter (mmol/L) | Standard Error 0.227 |
| GW642444M 25 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Min Potassium, n=16, 20, 18, 6,12 | 4.03 Millimoles per liter (mmol/L) | Standard Error 0.053 |
| GW642444M 25 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Max Glucose, n=17, 20, 19, 6,10 | 6.61 Millimoles per liter (mmol/L) | Standard Error 0.37 |
| GW642444M 25 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Potassium, n=15, 16, 17, 5,12 | 4.29 Millimoles per liter (mmol/L) | Standard Error 0.067 |
| GW642444M 50 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Min Potassium, n=16, 20, 18, 6,12 | 3.97 Millimoles per liter (mmol/L) | Standard Error 0.052 |
| GW642444M 50 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Max Glucose, n=17, 20, 19, 6,10 | 6.65 Millimoles per liter (mmol/L) | Standard Error 0.342 |
| GW642444M 50 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Potassium, n=15, 16, 17, 5,12 | 4.14 Millimoles per liter (mmol/L) | Standard Error 0.057 |
| GW642444M 50 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Glucose, n=16,18,19,6,10 | 5.95 Millimoles per liter (mmol/L) | Standard Error 0.2 |
| GW642444M 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Glucose, n=16,18,19,6,10 | 6.25 Millimoles per liter (mmol/L) | Standard Error 0.345 |
| GW642444M 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Max Glucose, n=17, 20, 19, 6,10 | 6.99 Millimoles per liter (mmol/L) | Standard Error 0.608 |
| GW642444M 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Min Potassium, n=16, 20, 18, 6,12 | 4.08 Millimoles per liter (mmol/L) | Standard Error 0.082 |
| GW642444M 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Potassium, n=15, 16, 17, 5,12 | 4.22 Millimoles per liter (mmol/L) | Standard Error 0.102 |
| GW642444H 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Min Potassium, n=16, 20, 18, 6,12 | 4.08 Millimoles per liter (mmol/L) | Standard Error 0.065 |
| GW642444H 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Potassium, n=15, 16, 17, 5,12 | 4.27 Millimoles per liter (mmol/L) | Standard Error 0.073 |
| GW642444H 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | Max Glucose, n=17, 20, 19, 6,10 | 6.09 Millimoles per liter (mmol/L) | Standard Error 0.436 |
| GW642444H 100 µg | Weighted Mean and Maximum/Minimum Value (0 - 4 Hours) for Glucose and Potassium | WM Glucose, n=16,18,19,6,10 | 5.71 Millimoles per liter (mmol/L) | Standard Error 0.251 |
Secondary
Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure
Blood pressure (BP) measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. SBP and DBP were recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1,2, 3, 4 and 6 hours post-dose on Day 1of the each treatment period. SBP and DBP recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum SBP and DBP.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: PP Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM SBP | 126.92 Millimeters of mercury | Standard Error 1.223 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max SBP | 133.23 Millimeters of mercury | Standard Error 1.521 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM DBP | 80.36 Millimeters of mercury | Standard Error 1.017 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max DBP | 76.13 Millimeters of mercury | Standard Error 1.147 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM SBP | 126.28 Millimeters of mercury | Standard Error 1.388 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max DBP | 75.08 Millimeters of mercury | Standard Error 1.272 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max SBP | 133.06 Millimeters of mercury | Standard Error 1.714 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM DBP | 79.74 Millimeters of mercury | Standard Error 1.133 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max DBP | 76.30 Millimeters of mercury | Standard Error 1.189 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max SBP | 133.91 Millimeters of mercury | Standard Error 1.591 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM DBP | 80.04 Millimeters of mercury | Standard Error 1.056 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM SBP | 127.82 Millimeters of mercury | Standard Error 1.284 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM SBP | 128.99 Millimeters of mercury | Standard Error 2.146 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max SBP | 135.24 Millimeters of mercury | Standard Error 2.625 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max DBP | 79.92 Millimeters of mercury | Standard Error 1.917 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM DBP | 83.46 Millimeters of mercury | Standard Error 1.721 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max DBP | 71.63 Millimeters of mercury | Standard Error 1.478 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM DBP | 77.46 Millimeters of mercury | Standard Error 1.321 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | Max SBP | 131.13 Millimeters of mercury | Standard Error 1.994 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) of Supine Systolic and Diastolic Blood Pressure | WM SBP | 125.10 Millimeters of mercury | Standard Error 1.621 |
Secondary
Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F)
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the 12-lead ECG. QTcB is the QT interval corrected for heart rate using Bazett's formula; QTcF is the QT interval corrected for heart rate using Fridericia's formula. Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. QTcB and QTcF recorded at 20 minutes, 45 minutes, 1, 2, 3, and 4 hours post-dose on Day 1 of each treatment period were used for analysis. The data is presented as the adjusted means of WM and maximum QTc(B) and QTc(F).
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: PP Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcB | 419.68 Milliseconds (msec) | Standard Error 2.15 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcB | 439.37 Milliseconds (msec) | Standard Error 3.714 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcF, | 409.13 Milliseconds (msec) | Standard Error 1.696 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcF | 425.34 Milliseconds (msec) | Standard Error 2.9 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcB | 419.56 Milliseconds (msec) | Standard Error 2.378 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcF | 421.73 Milliseconds (msec) | Standard Error 3.286 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcB | 437.06 Milliseconds (msec) | Standard Error 4.104 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcF, | 408.31 Milliseconds (msec) | Standard Error 1.898 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcF | 422.55 Milliseconds (msec) | Standard Error 3.025 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcB | 434.62 Milliseconds (msec) | Standard Error 3.85 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcF, | 412.99 Milliseconds (msec) | Standard Error 1.76 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcB | 424.18 Milliseconds (msec) | Standard Error 2.23 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcB | 422.36 Milliseconds (msec) | Standard Error 3.517 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcB | 438.14 Milliseconds (msec) | Standard Error 6.059 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcF | 422.41 Milliseconds (msec) | Standard Error 5 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcF, | 409.50 Milliseconds (msec) | Standard Error 2.842 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcF | 422.99 Milliseconds (msec) | Standard Error 3.766 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcF, | 409.82 Milliseconds (msec) | Standard Error 2.163 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | Max QTcB | 436.75 Milliseconds (msec) | Standard Error 4.681 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) QTc(B) and QTc(F) | WM QTcB | 419.70 Milliseconds (msec) | Standard Error 2.714 |
Secondary
Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate
Weighted mean (WM) is derived by calculating the area under curve (AUC), and then dividing by the relevant time interval. Heart rate was recorded at Screening, prior to dosing, and at 20 minutes, 45 minutes, 1, 2, 3, 4 and 6 hours post-dose on Day 1of each treatment period. Heart rate recorded at 20 minutes, 45 minutes and 1, 2, 3 and 4 hours post-dose on Day 1of the each treatment period were used for analysis. Heart rate measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. The data is presented as adjusted mean of WM and maximum heart rate.
Time frame: Baseline and Day 1 of each treatment period (up to Study Day 54)
Population: PP Population. Only those participants available at the indicated time points were assessed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | WM Heart rate | 71.12 Beats per minute | Standard Error 1.32 |
| Placebo | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | Max Heart rate | 77.88 Beats per minute | Standard Error 1.784 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | WM Heart rate | 71.76 Beats per minute | Standard Error 1.473 |
| GW642444M 25 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | Max Heart rate | 79.95 Beats per minute | Standard Error 1.948 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | WM Heart rate | 71.57 Beats per minute | Standard Error 1.377 |
| GW642444M 50 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | Max Heart rate | 76.13 Beats per minute | Standard Error 1.845 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | Max Heart rate | 77.77 Beats per minute | Standard Error 2.764 |
| GW642444M 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | WM Heart rate | 73.50 Beats per minute | Standard Error 2.179 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | WM Heart rate | 71.22 Beats per minute | Standard Error 1.734 |
| GW642444H 100 µg | Weighted Mean and Maximum Value (0 - 4 Hours) Supine Heart Rate | Max Heart rate | 77.16 Beats per minute | Standard Error 2.248 |