Asthma
Conditions
Keywords
Asthma, Exercise Induced Asthma, Exercise Induced Bronchospasm
Brief summary
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.
Detailed description
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction. Subjects will be invited to complete a screening visit, during which time exercise induced bronchoconstriction must be demonstrated, defined as a decrease between 20-40% in FEV1 compared to baseline immediately following exercise challenge. Eligible subjects will complete a randomized, double-blind, five-way crossover study. Subjects will be randomized to a single dose of either 10 mg, 50 mg, 100 mg, 200 mg GSK2190915, or placebo during each treatment period. Each treatment period will last 2 days and will include various assessments following exercise challenge at 2, 9.5, and 24 hours post dose. A minimum 7 day washout between treatment periods will be required. Regardless if a subject completes or prematurely withdraws from the study, a follow up visit will be completed 7-21 days following last dose.
Interventions
DRUGPlacebo
The current study will include a placebo arm to allow for a valid evaluation of adverse events attributable to GSK2190915 versus those independent of GSK2190915.
DRUGGSK2190915
This study will assess FEV1 at various intervals following exercise challenge in subjects who have been administered a single dose of 10 mg, 50 mg, 100 mg, or 200 mg GSK2190915, compared to a placebo control.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 to 55 years inclusive. * Female subjects must be of non childbearing potential including pre-menopausal females with documented hysterectomy or double oophorectomy or tubal ligation or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL and estradiol \< 40 pg/ml (\<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Hormone replacement therapy (HRT) is permitted for post-menopausal females. * Male subjects must agree to use one of the protocol outlined contraception methods. This criterion must be followed from the time of the first dose of study medication until 3 months after administration of last dose. * Body weight greater than or equal to 50 kg and Body mass index within range of 18.5-35.0 kg/m2 inclusive. * Pre-bronchodilator FEV1 \>70% of predicted at screening. * Exercise induced bronchoconstriction, as defined as a 20-40% decrease in FEV1 compared to baseline immediately following exercise challenge at screening. * Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit with a pack history of less than or equal to 10 pack years \[number of pack years = (number of cigarettes per day/20) x number of years smoked\] * Has provided signed and dated written informed consent * Is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
Exclusion criteria
* Chronic use of inhaled corticosteroids (ICS) for the treatment of persistent asthma. * Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study or the subject's safety. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, gastrointestinal disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (with the exception of asthma, but including chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). * Treated for or diagnosed with clinical depression within six months of screening or has a history of significant psychiatric illness. * Known history of hypertension or is hypertensive at screening which, in the opinion of the Investigator, deems the subject unfit to complete exercise challenge. Hypertension at screening is defined as persistent systolic BP \>150 mmHg or diastolic BP \> 90mmHg. * Known history of gastrointestinal bleeding. * Respiratory tract infection within 2 weeks prior to the first dose of study medication. * Asthma exacerbations requiring treatment with oral corticosteroids: any exacerbations within 4 weeks of the screening visit or two or more exacerbations within 2 months of the screening visit or admittance to hospital for an asthma exacerbation within 6 months of the screening visit. * History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. * History of alcohol/drug abuse or dependence within 12 months of the study. Abuse of alcohol defined as an average weekly intake of \>14 drinks/week for men or \>7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits. * Use of prescription or non-prescription drugs (including CYP 3A4 inhibitors and inducers, vitamins and dietary or herbal supplements), from 14 days before screening until the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study. Inhaled beta-2 agonists and acetaminophen (up to 4 g per day) for the treatment of minor ailments, eg headache, are permitted. Hormone replacement therapy (HRT) is also permitted for post-menopausal females. * Unable to washout the following protocol defined prohibited medications within the defined times: Medication Exclusion Period Oral or injectable corticosteroids - No use within 5 weeks of the screening visit Inhaled, Intranasal and topical steroids - No use within 4 weeks of the screening visit Long acting beta-2 agonists - No use within 48 hours of an exercise challenge or dosing or lung function testing Short acting beta-2 agonists - No use within 6 hours of an exercise challenge or dosing or lung function testing * Following exercise challenge during the screening visit, the subject experiences a greater than 40% fall in FEV1 compared to baseline. * Following exercise challenge during the screening visit, the subject is not able to recover to at least 20% of baseline FEV1 following administration of short acting beta-2 agonists. * Requires rescue medication before all lung function assessments are completed following the exercise challenge at screening * Symptomatic with hay fever at screening or predicted to have symptomatic hayfever during the time of exercise challenge which, in the opinion of the Investigator, would interfere with the outcome of the study. * Participation in a study with a new molecular entity during the previous 3 months or 5 half-lives (whichever is longer), or participation in a study without a new molecular entity during the previous month or 5 half-lives (whichever is longer), prior to the first dose of study medication. * Undergoing allergen desensitisation therapy. * There is a risk of subject non-compliance with study procedures. * History of blood donation (500 mL) within 2 months of starting the clinical study. * A screening QTc value of \>450msec, PR interval outside the range 120 to 220msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave). * Positive pregnancy test for females. * Positive test for hepatitis C antibody or hepatitis B surface antigen. * Positive test for HIV antibodies. * Positive pre-study urine cotinine/ breath carbon monoxide test and or urine drug/urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines. * Has an affiliation with the Investigative Site. Participation of site personnel, or their spouses or children, is not allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period. | FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum (i.e., most negative) percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100\*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at \>=80% of the predicted value for 6 minutes), FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period. | FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge.Weighted mean FEV1 percentage change recorded during 0-60 minutes post challenge was determined for each challenge, by dividing area under curve (AUC) for percent change from Baseline FEV1 measurements at 5, 10, 15, 30, 45 and 60 minutes post challenge by time interval. Actual times were used to determine time interval where available; otherwise planned relative time was used. If one or more FEV1 values were missing, AUC was calculated over time interval of available values. If intermittent values were missing over a participant's profile,it was assumed to be linear between 2 available values for calculation of AUC. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. |
| Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period | The time from maximal percentage change in FEV1 to recovery to within 5% of pre challenge Baseline (in minutes) was derived using actual sampling times. Time to FEV1 recovery= \[SAS date/time of recovery(a) FEV1 - SAS date/time of FEV1 Maximum % Change0-60\] / 60, where a is earliest recorded FEV1 either above pre-challenge Baseline or within 5% below pre challenge Baseline. Any unscheduled FEV1 measurements taken after last scheduled post challenge measurement was considered when deriving this endpoint. A corresponding censoring variable was derived for analysis to indicate whether recovery to within 5% of pre-challenge Baseline was achieved. The censoring variable was set to 1 if recovery to within 5% of Baseline was achieved. If recovery was not evident from data collected, time to recovery was calculated using the date/time of the last available post challenge FEV1 assessment and censoring variable was set to zero. Analysis was performed using a Cox proportional hazards model. |
| Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | Baseline (pre dose) up to 24 Hours post dose of each treatment period | Analysis LTB4 levels in the blood samples indicated the extent of LTB4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. |
| Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 0 to 90 minutes following exercise challenge of each treatment period | Rescue medication was provided to participants at any time and it was strongly recommended for participants with a FEV1 decrease of at least 40% following exercise challenge compared to Baseline. Rescue medication was administered 0 to 90 minutes post exercise challenge. Statistical analysis was supposed to be performed using logistic regression, however, the data was too sparse to permit any formal statistical analysis. |
| Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period | All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for SBP and DBP for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge. |
| Assessment of Vital Signs: Heart Rate (HR) | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period | All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for HR for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period | All participants rested for at least 10 minutes in the supine position prior to ECG recordings. ECG Baseline values for each treatment period was calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours, 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours. Participants with not clinically significant (NCS) abnormal values were reported. Potential clinical importance range for the ECG parameters are as follows: absolute QTc interval \>450 millisecond (msec), increase from Baseline QTc \>60 msec, PR interval \<110 and \>220 msec and QRS interval \<75 and \>110 msec. No participants reported clinically significant abnormal values. |
| Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of clinical chemistry parameters for albumin and total protein at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of clinical chemistry parameters for ALP, ALT, AST and GGT at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of clinical chemistry parameters for direct bilirubin, total bilirubin and creatinine at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period. | FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100\*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at \>=80% of the predicted value for 6 minutes), the FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated. |
| Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of hematology parameters for basophils, eosinophils, lymphocytes, monocytes, TN, platelet count, WBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of hematology parameters for hemoglobin and MCHC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Hematology Parameters: Hematocrit | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of hematology parameters for hematocrit at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of hematology parameter for MCH at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of hematology parameter for MCV at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of hematology parameter for RBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to follow up (7 to 21 days) following last dose | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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, is a congenital anomaly/birth defect and medically significant. |
| Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | Baseline (pre dose) up to 24 Hours post dose of each treatment period | Analysis of LTE4 levels in the urine samples indicated the extent of LTE4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. |
| Derived Pharmacokinetic (PK) Parameters for GSK2190915 | Pre dose, 2 hours, 3.5 hours, 9.5 hours, 11 hours and 24 hours following exercise challenge of each treatment period | PK samples were supposed to be collected at 10 minutes prior to the exercise challenge at 2 hours, 9.5 hours and 24 hours. |
| Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Pre dose and 25 hours and 30 minutes post dose of each treatment period | Blood samples were collected for the assessment of clinical chemistry parameters for calcium, chloride, glucose, potassium, sodium and urea/BUN at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. Participants fasted for glucose blood sample. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose. |
Countries
United States
Participant flow
Recruitment details
This was a Phase IIa multi-center study conducted in the United States from 02 December 2008 to 15 July 2009.
Pre-assignment details
A total of 47 participants were randomized in the study who underwent a screening visit of 28 days prior to first dose of study medication.
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Washout Period 1 (7 Days) | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Washout Period 2 (7 Days) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Washout Period 3 (7 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Age, Continuous | 28.4 Years STANDARD_DEVIATION 8.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 41 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 | 0 / 44 | 0 / 45 | 0 / 47 | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 4 / 44 | 4 / 45 | 4 / 47 | 0 / 45 | 4 / 45 |
| serious Total, serious adverse events | 0 / 44 | 0 / 45 | 0 / 47 | 0 / 45 | 0 / 45 |
Outcome results
Primary
Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose
FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum (i.e., most negative) percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100\*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at \>=80% of the predicted value for 6 minutes), FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.
Time frame: Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period.
Population: The 'Efficacy Population' was defined as all participants who received at least one dose of study medication and are not major protocol violators.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | -7.61 Percent change | Standard Error 1.326 |
| GSK2190915 10 mg | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | -6.33 Percent change | Standard Error 1.314 |
| GSK2190915 50 mg | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | -7.09 Percent change | Standard Error 1.307 |
| GSK2190915 100 mg | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | -7.28 Percent change | Standard Error 1.314 |
| GSK2190915 200 mg | Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose | -5.09 Percent change | Standard Error 1.315 |
95% CI: [-1.56, 4.13]
95% CI: [-2.32, 3.37]
95% CI: [-2.52, 3.18]
95% CI: [-0.31, 5.37]
Secondary
Assessment of Clinical Chemistry Parameters: Albumin, Total Protein
Blood samples were collected for the assessment of clinical chemistry parameters for albumin and total protein at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, 25Hours 30minutes | 73.2 Gram/liter (G/L) | Standard Deviation 4 |
| Placebo | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, Pre dose 1 | 71.9 Gram/liter (G/L) | Standard Deviation 5.32 |
| Placebo | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, Pre dose 1 | 44.5000 Gram/liter (G/L) | Standard Deviation 3.30961 |
| Placebo | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, 25Hours 30minutes | 45.8140 Gram/liter (G/L) | Standard Deviation 2.23879 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, 25Hours 30minutes | 45.4222 Gram/liter (G/L) | Standard Deviation 3.08581 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, Pre dose 1 | 44.9091 Gram/liter (G/L) | Standard Deviation 2.60427 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, 25Hours 30minutes | 72.9 Gram/liter (G/L) | Standard Deviation 3.59 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, Pre dose 1 | 72.5 Gram/liter (G/L) | Standard Deviation 4.05 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, Pre dose 1 | 71.4 Gram/liter (G/L) | Standard Deviation 5.11 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, 25Hours 30minutes | 73.5 Gram/liter (G/L) | Standard Deviation 3.97 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, Pre dose 1 | 44.4894 Gram/liter (G/L) | Standard Deviation 3.24956 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, 25Hours 30minutes | 45.7021 Gram/liter (G/L) | Standard Deviation 2.43091 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, 25Hours 30minutes | 72.6 Gram/liter (G/L) | Standard Deviation 2.73 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, Pre dose 1 | 71.6 Gram/liter (G/L) | Standard Deviation 4.16 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, 25Hours 30minutes | 45.9111 Gram/liter (G/L) | Standard Deviation 2.16188 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, Pre dose 1 | 44.8667 Gram/liter (G/L) | Standard Deviation 2.54594 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, 25Hours 30minutes | 72.8 Gram/liter (G/L) | Standard Deviation 3.72 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, Pre dose 1 | 44.9778 Gram/liter (G/L) | Standard Deviation 3.20148 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Albumin, 25Hours 30minutes | 45.8444 Gram/liter (G/L) | Standard Deviation 2.53122 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Albumin, Total Protein | Total protein, Pre dose 1 | 71.3 Gram/liter (G/L) | Standard Deviation 4.78 |
Secondary
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT)
Blood samples were collected for the assessment of clinical chemistry parameters for ALP, ALT, AST and GGT at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, Pre dose 1 | 76.6 International units per liter (IU/L) | Standard Deviation 26.15 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, 25 Hours 30 minutes | 75.3 International units per liter (IU/L) | Standard Deviation 23.26 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, Pre dose 1 | 30.7 International units per liter (IU/L) | Standard Deviation 19.09 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, 25 Hours 30 minutes | 31.7 International units per liter (IU/L) | Standard Deviation 20.04 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, Pre dose 1 | 24.5 International units per liter (IU/L) | Standard Deviation 13.29 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, 25 Hours 30 minutes | 24.0 International units per liter (IU/L) | Standard Deviation 10.14 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, Pre dose 1 | 29.8 International units per liter (IU/L) | Standard Deviation 29.45 |
| Placebo | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, 2 5Hours 30 minutes | 29.5 International units per liter (IU/L) | Standard Deviation 25.87 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, Pre dose 1 | 30.1 International units per liter (IU/L) | Standard Deviation 17.66 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, 25 Hours 30 minutes | 23.3 International units per liter (IU/L) | Standard Deviation 8.82 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, Pre dose 1 | 75.5 International units per liter (IU/L) | Standard Deviation 24.29 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, 25 Hours 30 minutes | 29.6 International units per liter (IU/L) | Standard Deviation 16.08 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, 25 Hours 30 minutes | 75.7 International units per liter (IU/L) | Standard Deviation 23.75 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, 2 5Hours 30 minutes | 27.7 International units per liter (IU/L) | Standard Deviation 20.81 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, Pre dose 1 | 24.0 International units per liter (IU/L) | Standard Deviation 10.26 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, Pre dose 1 | 28.1 International units per liter (IU/L) | Standard Deviation 21.98 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, Pre dose 1 | 31.5 International units per liter (IU/L) | Standard Deviation 27.08 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, 2 5Hours 30 minutes | 32.9 International units per liter (IU/L) | Standard Deviation 29.08 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, 25 Hours 30 minutes | 32.4 International units per liter (IU/L) | Standard Deviation 19.49 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, 25 Hours 30 minutes | 27.3 International units per liter (IU/L) | Standard Deviation 19.39 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, Pre dose 1 | 31.2 International units per liter (IU/L) | Standard Deviation 18.97 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, 25 Hours 30 minutes | 76.9 International units per liter (IU/L) | Standard Deviation 27.15 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, Pre dose 1 | 75.6 International units per liter (IU/L) | Standard Deviation 25.64 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, Pre dose 1 | 25.4 International units per liter (IU/L) | Standard Deviation 14.81 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, 25 Hours 30 minutes | 75.2 International units per liter (IU/L) | Standard Deviation 23.71 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, Pre dose 1 | 32.2 International units per liter (IU/L) | Standard Deviation 26.62 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, 25 Hours 30 minutes | 31.4 International units per liter (IU/L) | Standard Deviation 23.34 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, Pre dose 1 | 24.6 International units per liter (IU/L) | Standard Deviation 11.42 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, 25 Hours 30 minutes | 23.9 International units per liter (IU/L) | Standard Deviation 9.72 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, 2 5Hours 30 minutes | 32.8 International units per liter (IU/L) | Standard Deviation 38.13 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, Pre dose 1 | 74.6 International units per liter (IU/L) | Standard Deviation 23.85 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, Pre dose 1 | 32.8 International units per liter (IU/L) | Standard Deviation 39.54 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, 25 Hours 30 minutes | 38.5 International units per liter (IU/L) | Standard Deviation 66.01 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, 2 5Hours 30 minutes | 31.0 International units per liter (IU/L) | Standard Deviation 31.83 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALT, Pre dose 1 | 39.6 International units per liter (IU/L) | Standard Deviation 71.33 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | GGT, Pre dose 1 | 30.3 International units per liter (IU/L) | Standard Deviation 30.77 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, Pre dose 1 | 75.3 International units per liter (IU/L) | Standard Deviation 22.69 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, 25 Hours 30 minutes | 26.9 International units per liter (IU/L) | Standard Deviation 31.33 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | ALP, 25 Hours 30 minutes | 75.8 International units per liter (IU/L) | Standard Deviation 25.73 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) | AST, Pre dose 1 | 27.3 International units per liter (IU/L) | Standard Deviation 31.46 |
Secondary
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN)
Blood samples were collected for the assessment of clinical chemistry parameters for calcium, chloride, glucose, potassium, sodium and urea/BUN at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. Participants fasted for glucose blood sample. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, 25 Hours 30 minutes | 4.43 Millimole per liter (mmol/L) | Standard Deviation 0.342 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, Pre dose 1 | 5.8175 Millimole per liter (mmol/L) | Standard Deviation 1.32593 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, Pre dose 1 | 2.35494 Millimole per liter (mmol/L) | Standard Deviation 0.112125 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, 25 Hours 30 minutes | 104.7 Millimole per liter (mmol/L) | Standard Deviation 2.36 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, 25 Hours 30 minutes | 4.99203 Millimole per liter (mmol/L) | Standard Deviation 0.859137 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, 25 Hours 30 minutes | 5.6539 Millimole per liter (mmol/L) | Standard Deviation 1.12605 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, 25 Hours 30 minutes | 140.0 Millimole per liter (mmol/L) | Standard Deviation 2.13 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, Pre dose 1 | 105.2 Millimole per liter (mmol/L) | Standard Deviation 1.92 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, Pre dose 1 | 4.80162 Millimole per liter (mmol/L) | Standard Deviation 0.783522 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, Pre dose 1 | 4.40 Millimole per liter (mmol/L) | Standard Deviation 0.328 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, 25 Hours 30 minutes | 2.37605 Millimole per liter (mmol/L) | Standard Deviation 0.105831 |
| Placebo | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, Pre dose 1 | 140.6 Millimole per liter (mmol/L) | Standard Deviation 2.16 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, 25 Hours 30 minutes | 5.5930 Millimole per liter (mmol/L) | Standard Deviation 1.11343 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, 25 Hours 30 minutes | 4.96753 Millimole per liter (mmol/L) | Standard Deviation 0.8923 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, 25 Hours 30 minutes | 2.38300 Millimole per liter (mmol/L) | Standard Deviation 0.11064 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, Pre dose 1 | 4.40 Millimole per liter (mmol/L) | Standard Deviation 0.456 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, Pre dose 1 | 2.36061 Millimole per liter (mmol/L) | Standard Deviation 0.107377 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, Pre dose 1 | 5.6390 Millimole per liter (mmol/L) | Standard Deviation 1.56766 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, Pre dose 1 | 105.1 Millimole per liter (mmol/L) | Standard Deviation 2.04 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, 25 Hours 30 minutes | 4.51 Millimole per liter (mmol/L) | Standard Deviation 0.362 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, 25 Hours 30 minutes | 140.6 Millimole per liter (mmol/L) | Standard Deviation 2.34 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, 25 Hours 30 minutes | 105.4 Millimole per liter (mmol/L) | Standard Deviation 1.85 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, Pre dose 1 | 140.9 Millimole per liter (mmol/L) | Standard Deviation 2.23 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, Pre dose 1 | 4.73601 Millimole per liter (mmol/L) | Standard Deviation 0.804663 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, Pre dose 1 | 5.7652 Millimole per liter (mmol/L) | Standard Deviation 1.24779 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, Pre dose 1 | 2.35910 Millimole per liter (mmol/L) | Standard Deviation 0.112041 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, 25 Hours 30 minutes | 2.39308 Millimole per liter (mmol/L) | Standard Deviation 0.096186 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, Pre dose 1 | 105.2 Millimole per liter (mmol/L) | Standard Deviation 2.07 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, 25 Hours 30 minutes | 105.2 Millimole per liter (mmol/L) | Standard Deviation 2.28 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, Pre dose 1 | 4.97937 Millimole per liter (mmol/L) | Standard Deviation 0.843434 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, 25 Hours 30 minutes | 4.73370 Millimole per liter (mmol/L) | Standard Deviation 0.82446 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, Pre dose 1 | 4.31 Millimole per liter (mmol/L) | Standard Deviation 0.386 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, 25 Hours 30 minutes | 4.44 Millimole per liter (mmol/L) | Standard Deviation 0.374 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, Pre dose 1 | 140.1 Millimole per liter (mmol/L) | Standard Deviation 2.17 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, 25 Hours 30 minutes | 140.3 Millimole per liter (mmol/L) | Standard Deviation 2.18 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, 25 Hours 30 minutes | 5.7424 Millimole per liter (mmol/L) | Standard Deviation 1.06537 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, 25 Hours 30 minutes | 5.02921 Millimole per liter (mmol/L) | Standard Deviation 1.00473 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, Pre dose 1 | 2.35417 Millimole per liter (mmol/L) | Standard Deviation 0.109681 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, 25 Hours 30 minutes | 4.44 Millimole per liter (mmol/L) | Standard Deviation 0.322 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, Pre dose 1 | 4.88735 Millimole per liter (mmol/L) | Standard Deviation 0.770075 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, Pre dose 1 | 139.9 Millimole per liter (mmol/L) | Standard Deviation 2.37 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, 25 Hours 30 minutes | 104.8 Millimole per liter (mmol/L) | Standard Deviation 2.05 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, 25 Hours 30 minutes | 5.8786 Millimole per liter (mmol/L) | Standard Deviation 1.09666 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, 25 Hours 30 minutes | 139.6 Millimole per liter (mmol/L) | Standard Deviation 2.03 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, Pre dose 1 | 105.0 Millimole per liter (mmol/L) | Standard Deviation 2.34 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, 25 Hours 30 minutes | 2.38078 Millimole per liter (mmol/L) | Standard Deviation 0.091593 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, Pre dose 1 | 5.7120 Millimole per liter (mmol/L) | Standard Deviation 1.25759 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, Pre dose 1 | 4.29 Millimole per liter (mmol/L) | Standard Deviation 0.32 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, 25 Hours 30 minutes | 5.07855 Millimole per liter (mmol/L) | Standard Deviation 1.164605 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, 25 Hours 30 minutes | 140.2 Millimole per liter (mmol/L) | Standard Deviation 2.14 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, Pre dose 1 | 2.35084 Millimole per liter (mmol/L) | Standard Deviation 0.108088 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, 25 Hours 30 minutes | 4.50 Millimole per liter (mmol/L) | Standard Deviation 0.333 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Calcium, 25 Hours 30 minutes | 2.37136 Millimole per liter (mmol/L) | Standard Deviation 0.093348 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, 25 Hours 30 minutes | 105.5 Millimole per liter (mmol/L) | Standard Deviation 2.29 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, 25 Hours 30 minutes | 5.5771 Millimole per liter (mmol/L) | Standard Deviation 1.30126 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Glucose, Pre dose 1 | 4.95273 Millimole per liter (mmol/L) | Standard Deviation 0.768704 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Sodium, Pre dose 1 | 140.2 Millimole per liter (mmol/L) | Standard Deviation 1.87 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Potassium, Pre dose 1 | 4.36 Millimole per liter (mmol/L) | Standard Deviation 0.422 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Chloride, Pre dose 1 | 105.1 Millimole per liter (mmol/L) | Standard Deviation 2.42 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN) | Urea/BUN, Pre dose 1 | 5.6565 Millimole per liter (mmol/L) | Standard Deviation 1.31601 |
Secondary
Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine
Blood samples were collected for the assessment of clinical chemistry parameters for direct bilirubin, total bilirubin and creatinine at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, Pre dose 1 | 10.804 Micromoles per liter (µmol/L) | Standard Deviation 5.6386 |
| Placebo | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, 25 Hours 30 minutes | 10.737 Micromoles per liter (µmol/L) | Standard Deviation 5.3078 |
| Placebo | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, Pre dose 1 | 2.361 Micromoles per liter (µmol/L) | Standard Deviation 1.8484 |
| Placebo | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, 25 Hours 30 minute | 2.443 Micromoles per liter (µmol/L) | Standard Deviation 1.8938 |
| Placebo | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, 25 Hours 30 minutes | 85.83023 Micromoles per liter (µmol/L) | Standard Deviation 14.40704 |
| Placebo | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, Pre dose 1 | 83.96594 Micromoles per liter (µmol/L) | Standard Deviation 18.34701 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, Pre dose 1 | 11.348 Micromoles per liter (µmol/L) | Standard Deviation 5.0173 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, 25 Hours 30 minutes | 86.71058 Micromoles per liter (µmol/L) | Standard Deviation 14.11612 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, 25 Hours 30 minutes | 10.412 Micromoles per liter (µmol/L) | Standard Deviation 4.8479 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, Pre dose 1 | 87.93791 Micromoles per liter (µmol/L) | Standard Deviation 20.15153 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, 25 Hours 30 minute | 2.204 Micromoles per liter (µmol/L) | Standard Deviation 1.2952 |
| GSK2190915 10 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, Pre dose 1 | 2.332 Micromoles per liter (µmol/L) | Standard Deviation 1.4326 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, Pre dose 1 | 86.23702 Micromoles per liter (µmol/L) | Standard Deviation 13.21355 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, 25 Hours 30 minutes | 87.91098 Micromoles per liter (µmol/L) | Standard Deviation 13.81935 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, 25 Hours 30 minute | 2.453 Micromoles per liter (µmol/L) | Standard Deviation 2.3266 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, Pre dose 1 | 11.060 Micromoles per liter (µmol/L) | Standard Deviation 5.6473 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, Pre dose 1 | 2.230 Micromoles per liter (µmol/L) | Standard Deviation 1.8336 |
| GSK2190915 50 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, 25 Hours 30 minutes | 11.388 Micromoles per liter (µmol/L) | Standard Deviation 6.127 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, Pre dose 1 | 86.80880 Micromoles per liter (µmol/L) | Standard Deviation 13.90414 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, 25 Hours 30 minutes | 10.982 Micromoles per liter (µmol/L) | Standard Deviation 5.8387 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, Pre dose 1 | 2.318 Micromoles per liter (µmol/L) | Standard Deviation 1.6769 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, 25 Hours 30 minute | 2.584 Micromoles per liter (µmol/L) | Standard Deviation 1.8454 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, 25 Hours 30 minutes | 87.57493 Micromoles per liter (µmol/L) | Standard Deviation 13.41632 |
| GSK2190915 100 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, Pre dose 1 | 11.438 Micromoles per liter (µmol/L) | Standard Deviation 5.8652 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, 25 Hours 30 minutes | 87.57493 Micromoles per liter (µmol/L) | Standard Deviation 14.84895 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, Pre dose 1 | 2.280 Micromoles per liter (µmol/L) | Standard Deviation 2.1874 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Direct Bilirubin, 25 Hours 30 minute | 2.242 Micromoles per liter (µmol/L) | Standard Deviation 1.923 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, Pre dose 1 | 11.134 Micromoles per liter (µmol/L) | Standard Deviation 7.3966 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Total Bilirubin, 25 Hours 30 minutes | 10.906 Micromoles per liter (µmol/L) | Standard Deviation 6.4426 |
| GSK2190915 200 mg | Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine | Creatinine, Pre dose 1 | 85.96409 Micromoles per liter (µmol/L) | Standard Deviation 14.50499 |
Secondary
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC)
Blood samples were collected for the assessment of hematology parameters for basophils, eosinophils, lymphocytes, monocytes, TN, platelet count, WBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, Pre dose 1 | 0.0306 Cells x 10^9 per liter | Standard Deviation 0.01326 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, Pre dose 1 | 3.4340 Cells x 10^9 per liter | Standard Deviation 0.98614 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, Pre dose 1 | 0.4673 Cells x 10^9 per liter | Standard Deviation 0.18438 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, 25 Hours 30 minutes | 0.3912 Cells x 10^9 per liter | Standard Deviation 0.09575 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, Pre dose 1 | 6.69 Cells x 10^9 per liter | Standard Deviation 1.689 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, Pre dose 1 | 0.2638 Cells x 10^9 per liter | Standard Deviation 0.21459 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, 25 Hours 30 minutes | 242.7 Cells x 10^9 per liter | Standard Deviation 55.97 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, 25 Hours 30 minutes | 0.2241 Cells x 10^9 per liter | Standard Deviation 0.15104 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, 25 Hours 30 minutes | 6.56 Cells x 10^9 per liter | Standard Deviation 1.708 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, Pre dose 1 | 241.8 Cells x 10^9 per liter | Standard Deviation 58.19 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, Pre dose 1 | 2.2320 Cells x 10^9 per liter | Standard Deviation 0.62143 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, 25 Hours 30 minutes | 0.0242 Cells x 10^9 per liter | Standard Deviation 0.01064 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, 25 Hours 30 minutes | 3.6062 Cells x 10^9 per liter | Standard Deviation 1.16759 |
| Placebo | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, 25 Hours 30 minutes | 1.8281 Cells x 10^9 per liter | Standard Deviation 0.47068 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, 25 Hours 30 minutes | 1.8847 Cells x 10^9 per liter | Standard Deviation 0.55807 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, Pre dose 1 | 2.2139 Cells x 10^9 per liter | Standard Deviation 0.56983 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, 25 Hours 30 minutes | 0.2610 Cells x 10^9 per liter | Standard Deviation 0.18803 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, Pre dose 1 | 0.4366 Cells x 10^9 per liter | Standard Deviation 0.11641 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, 25 Hours 30 minutes | 0.0303 Cells x 10^9 per liter | Standard Deviation 0.00968 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, 25 Hours 30 minutes | 0.4289 Cells x 10^9 per liter | Standard Deviation 0.12575 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, Pre dose 1 | 3.3645 Cells x 10^9 per liter | Standard Deviation 0.92934 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, Pre dose 1 | 0.0281 Cells x 10^9 per liter | Standard Deviation 0.01065 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, Pre dose 1 | 6.58 Cells x 10^9 per liter | Standard Deviation 1.638 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, Pre dose 1 | 238.0 Cells x 10^9 per liter | Standard Deviation 51.85 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, 25 Hours 30 minutes | 3.6962 Cells x 10^9 per liter | Standard Deviation 0.92202 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, Pre dose 1 | 0.2574 Cells x 10^9 per liter | Standard Deviation 0.206 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, 25 Hours 30 minutes | 6.56 Cells x 10^9 per liter | Standard Deviation 1.434 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, 25 Hours 30 minutes | 239.0 Cells x 10^9 per liter | Standard Deviation 48.39 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, 25 Hours 30 minutes | 1.9052 Cells x 10^9 per liter | Standard Deviation 0.48399 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, Pre dose 1 | 0.0276 Cells x 10^9 per liter | Standard Deviation 0.01133 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, 25 Hours 30 minutes | 0.0333 Cells x 10^9 per liter | Standard Deviation 0.01805 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, Pre dose 1 | 0.2392 Cells x 10^9 per liter | Standard Deviation 0.15458 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, 25 Hours 30 minutes | 0.2431 Cells x 10^9 per liter | Standard Deviation 0.15657 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, Pre dose 1 | 2.3156 Cells x 10^9 per liter | Standard Deviation 0.56904 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, Pre dose 1 | 0.4799 Cells x 10^9 per liter | Standard Deviation 0.10725 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, 25 Hours 30 minutes | 0.4489 Cells x 10^9 per liter | Standard Deviation 0.13018 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, Pre dose 1 | 3.4151 Cells x 10^9 per liter | Standard Deviation 0.96375 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, 25 Hours 30 minutes | 3.7720 Cells x 10^9 per liter | Standard Deviation 1.088 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, Pre dose 1 | 243.0 Cells x 10^9 per liter | Standard Deviation 47.46 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, 25 Hours 30 minutes | 243.3 Cells x 10^9 per liter | Standard Deviation 46.73 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, Pre dose 1 | 6.77 Cells x 10^9 per liter | Standard Deviation 1.627 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, 25 Hours 30 minutes | 6.67 Cells x 10^9 per liter | Standard Deviation 1.605 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, 25 Hours 30 minutes | 1.8809 Cells x 10^9 per liter | Standard Deviation 0.49456 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, Pre dose 1 | 3.6047 Cells x 10^9 per liter | Standard Deviation 1.19442 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, Pre dose 1 | 2.3581 Cells x 10^9 per liter | Standard Deviation 0.66985 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, 25 Hours 30 minutes | 3.7813 Cells x 10^9 per liter | Standard Deviation 1.26257 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, 25 Hours 30 minutes | 0.2271 Cells x 10^9 per liter | Standard Deviation 0.18567 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, Pre dose 1 | 0.0316 Cells x 10^9 per liter | Standard Deviation 0.02112 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, Pre dose 1 | 240.1 Cells x 10^9 per liter | Standard Deviation 50.26 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, Pre dose 1 | 0.2563 Cells x 10^9 per liter | Standard Deviation 0.21963 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, 25 Hours 30 minutes | 240.5 Cells x 10^9 per liter | Standard Deviation 50.51 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, 25 Hours 30 minutes | 0.0282 Cells x 10^9 per liter | Standard Deviation 0.00944 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, 25 Hours 30 minutes | 6.75 Cells x 10^9 per liter | Standard Deviation 1.65 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, Pre dose 1 | 0.4671 Cells x 10^9 per liter | Standard Deviation 0.11368 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, Pre dose 1 | 6.79 Cells x 10^9 per liter | Standard Deviation 1.726 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, 25 Hours 30 minutes | 0.4190 Cells x 10^9 per liter | Standard Deviation 0.11797 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, Pre dose 1 | 0.4307 Cells x 10^9 per liter | Standard Deviation 0.1269 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, 25 Hours 30 minutes | 6.39 Cells x 10^9 per liter | Standard Deviation 1.681 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, Pre dose 1 | 3.5448 Cells x 10^9 per liter | Standard Deviation 1.05765 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, Pre dose 1 | 2.1852 Cells x 10^9 per liter | Standard Deviation 0.69204 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Monocyte, 25 Hours 30 minutes | 0.4084 Cells x 10^9 per liter | Standard Deviation 0.15112 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, Pre dose 1 | 0.0298 Cells x 10^9 per liter | Standard Deviation 0.01261 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, 25 Hours 30 minutes | 238.0 Cells x 10^9 per liter | Standard Deviation 52.59 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | TN, 25 Hours 30 minutes | 3.5289 Cells x 10^9 per liter | Standard Deviation 1.13473 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, 25 Hours 30 minutes | 0.1974 Cells x 10^9 per liter | Standard Deviation 0.10502 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Basophils, 25 Hours 30 minutes | 0.0252 Cells x 10^9 per liter | Standard Deviation 0.01171 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Lymphocyte, 25 Hours 30 minutes | 1.8677 Cells x 10^9 per liter | Standard Deviation 0.62646 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | WBC count, Pre dose 1 | 6.50 Cells x 10^9 per liter | Standard Deviation 1.465 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Plateletcount, Pre dose 1 | 238.4 Cells x 10^9 per liter | Standard Deviation 49.15 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC) | Eosinophils, Pre dose 1 | 0.2166 Cells x 10^9 per liter | Standard Deviation 0.112 |
Secondary
Assessment of Hematology Parameters: Hematocrit
Blood samples were collected for the assessment of hematology parameters for hematocrit at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Hematology Parameters: Hematocrit | Pre dose 1 | 0.4463 Ratio | Standard Deviation 0.0372 |
| Placebo | Assessment of Hematology Parameters: Hematocrit | 25 Hours 30 Minutes | 0.4440 Ratio | Standard Deviation 0.03186 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Hematocrit | Pre dose 1 | 0.4503 Ratio | Standard Deviation 0.03423 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Hematocrit | 25 Hours 30 Minutes | 0.4451 Ratio | Standard Deviation 0.03765 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Hematocrit | Pre dose 1 | 0.4431 Ratio | Standard Deviation 0.03885 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Hematocrit | 25 Hours 30 Minutes | 0.4453 Ratio | Standard Deviation 0.03375 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Hematocrit | 25 Hours 30 Minutes | 0.4442 Ratio | Standard Deviation 0.03244 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Hematocrit | Pre dose 1 | 0.4480 Ratio | Standard Deviation 0.03265 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Hematocrit | Pre dose 1 | 0.4465 Ratio | Standard Deviation 0.03864 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Hematocrit | 25 Hours 30 Minutes | 0.4448 Ratio | Standard Deviation 0.03628 |
Secondary
Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)
Blood samples were collected for the assessment of hematology parameters for hemoglobin and MCHC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, Pre dose 1 | 152.0 G/L | Standard Deviation 13.75 |
| Placebo | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, 25 hours 30 minutes | 151.1 G/L | Standard Deviation 12.84 |
| Placebo | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, Pre dose 1 | 340.5 G/L | Standard Deviation 8.55 |
| Placebo | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, 25 hours 30 minutes | 340.2 G/L | Standard Deviation 9.14 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, Pre dose 1 | 152.9 G/L | Standard Deviation 13 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, 25 hours 30 minutes | 341.1 G/L | Standard Deviation 7.43 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, 25 hours 30 minutes | 151.9 G/L | Standard Deviation 13.8 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, Pre dose 1 | 339.3 G/L | Standard Deviation 8.77 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, 25 hours 30 minutes | 340.4 G/L | Standard Deviation 9.3 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, 25 hours 30 minutes | 157.8 G/L | Standard Deviation 45.11 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, Pre dose 1 | 341.2 G/L | Standard Deviation 8.35 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, Pre dose 1 | 151.3 G/L | Standard Deviation 14.44 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, Pre dose 1 | 152.4 G/L | Standard Deviation 12.95 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, 25 hours 30 minutes | 151.3 G/L | Standard Deviation 12.93 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, 25 hours 30 minutes | 340.4 G/L | Standard Deviation 9.05 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, Pre dose 1 | 340.0 G/L | Standard Deviation 8.88 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, 25 hours 30 minutes | 339.8 G/L | Standard Deviation 9.96 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC, Pre dose 1 | 338.6 G/L | Standard Deviation 9.4 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, 25 hours 30 minutes | 151.2 G/L | Standard Deviation 13.41 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin, Pre dose 1 | 151.3 G/L | Standard Deviation 14.58 |
Secondary
Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH)
Blood samples were collected for the assessment of hematology parameter for MCH at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | Pre dose 1 | 30.27 Picograms | Standard Deviation 2.078 |
| Placebo | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | 25 Hours 30 Minutes | 30.19 Picograms | Standard Deviation 2.157 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | Pre dose 1 | 30.14 Picograms | Standard Deviation 2.122 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | 25 Hours 30 Minutes | 30.20 Picograms | Standard Deviation 2.05 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | Pre dose 1 | 30.30 Picograms | Standard Deviation 2.032 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | 25 Hours 30 Minutes | 30.27 Picograms | Standard Deviation 2.076 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | 25 Hours 30 Minutes | 30.18 Picograms | Standard Deviation 2.05 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | Pre dose 1 | 30.25 Picograms | Standard Deviation 2.024 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | Pre dose 1 | 30.14 Picograms | Standard Deviation 2.008 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH) | 25 Hours 30 Minutes | 30.32 Picograms | Standard Deviation 2.102 |
Secondary
Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV)
Blood samples were collected for the assessment of hematology parameter for MCV at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | Pre dose 1 | 88.85 Femtoliter | Standard Deviation 5.589 |
| Placebo | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | 25 Hours 30 Minutes | 88.74 Femtoliter | Standard Deviation 6.116 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | Pre dose 1 | 88.75 Femtoliter | Standard Deviation 5.5 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | 25 Hours 30 Minutes | 88.57 Femtoliter | Standard Deviation 5.612 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | Pre dose 1 | 88.80 Femtoliter | Standard Deviation 5.464 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | 25 Hours 30 Minutes | 88.89 Femtoliter | Standard Deviation 5.696 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | 25 Hours 30 Minutes | 88.69 Femtoliter | Standard Deviation 5.625 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | Pre dose 1 | 88.96 Femtoliter | Standard Deviation 5.673 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | Pre dose 1 | 89.06 Femtoliter | Standard Deviation 5.703 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV) | 25 Hours 30 Minutes | 89.23 Femtoliter | Standard Deviation 5.73 |
Secondary
Assessment of Hematology Parameters: Red Blood Cell Count (RBC)
Blood samples were collected for the assessment of hematology parameter for RBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.
Time frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period
Population: All Subjects Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | Pre dose 1 | 5.038 Cells x 10^12 per liter | Standard Deviation 0.4699 |
| Placebo | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | 25 Hours 30 Minutes | 5.018 Cells x 10^12 per liter | Standard Deviation 0.3819 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | Pre dose 1 | 5.086 Cells x 10^12 per liter | Standard Deviation 0.4255 |
| GSK2190915 10 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | 25 Hours 30 Minutes | 5.039 Cells x 10^12 per liter | Standard Deviation 0.4533 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | Pre dose 1 | 5.005 Cells x 10^12 per liter | Standard Deviation 0.4853 |
| GSK2190915 50 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | 25 Hours 30 Minutes | 5.023 Cells x 10^12 per liter | Standard Deviation 0.4253 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | 25 Hours 30 Minutes | 5.025 Cells x 10^12 per liter | Standard Deviation 0.4112 |
| GSK2190915 100 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | Pre dose 1 | 5.050 Cells x 10^12 per liter | Standard Deviation 0.4044 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | Pre dose 1 | 5.030 Cells x 10^12 per liter | Standard Deviation 0.4756 |
| GSK2190915 200 mg | Assessment of Hematology Parameters: Red Blood Cell Count (RBC) | 25 Hours 30 Minutes | 4.998 Cells x 10^12 per liter | Standard Deviation 0.4557 |
Secondary
Assessment of Vital Signs: Heart Rate (HR)
All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for HR for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.
Time frame: Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period
Population: All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Vital Signs: Heart Rate (HR) | Mean Pre Dose | 64.0 Beats per minute | Standard Deviation 9.2 |
| Placebo | Assessment of Vital Signs: Heart Rate (HR) | 2 Hours, Pre Exercise | 67.5 Beats per minute | Standard Deviation 8.78 |
| Placebo | Assessment of Vital Signs: Heart Rate (HR) | 9.5 Hours, Pre Exercise | 72.9 Beats per minute | Standard Deviation 11.35 |
| Placebo | Assessment of Vital Signs: Heart Rate (HR) | 24 Hours, Pre Excercise | 68.3 Beats per minute | Standard Deviation 10.9 |
| GSK2190915 10 mg | Assessment of Vital Signs: Heart Rate (HR) | Mean Pre Dose | 63.0 Beats per minute | Standard Deviation 7.62 |
| GSK2190915 10 mg | Assessment of Vital Signs: Heart Rate (HR) | 24 Hours, Pre Excercise | 65.7 Beats per minute | Standard Deviation 8.32 |
| GSK2190915 10 mg | Assessment of Vital Signs: Heart Rate (HR) | 2 Hours, Pre Exercise | 66.2 Beats per minute | Standard Deviation 9.08 |
| GSK2190915 10 mg | Assessment of Vital Signs: Heart Rate (HR) | 9.5 Hours, Pre Exercise | 69.4 Beats per minute | Standard Deviation 8.97 |
| GSK2190915 50 mg | Assessment of Vital Signs: Heart Rate (HR) | 24 Hours, Pre Excercise | 67.7 Beats per minute | Standard Deviation 8.75 |
| GSK2190915 50 mg | Assessment of Vital Signs: Heart Rate (HR) | 9.5 Hours, Pre Exercise | 72.8 Beats per minute | Standard Deviation 9.16 |
| GSK2190915 50 mg | Assessment of Vital Signs: Heart Rate (HR) | Mean Pre Dose | 64.0 Beats per minute | Standard Deviation 7.78 |
| GSK2190915 50 mg | Assessment of Vital Signs: Heart Rate (HR) | 2 Hours, Pre Exercise | 67.2 Beats per minute | Standard Deviation 8.51 |
| GSK2190915 100 mg | Assessment of Vital Signs: Heart Rate (HR) | Mean Pre Dose | 63.6 Beats per minute | Standard Deviation 7.48 |
| GSK2190915 100 mg | Assessment of Vital Signs: Heart Rate (HR) | 24 Hours, Pre Excercise | 65.9 Beats per minute | Standard Deviation 8.03 |
| GSK2190915 100 mg | Assessment of Vital Signs: Heart Rate (HR) | 2 Hours, Pre Exercise | 66.8 Beats per minute | Standard Deviation 6.95 |
| GSK2190915 100 mg | Assessment of Vital Signs: Heart Rate (HR) | 9.5 Hours, Pre Exercise | 72.3 Beats per minute | Standard Deviation 8.27 |
| GSK2190915 200 mg | Assessment of Vital Signs: Heart Rate (HR) | 24 Hours, Pre Excercise | 65.6 Beats per minute | Standard Deviation 9.31 |
| GSK2190915 200 mg | Assessment of Vital Signs: Heart Rate (HR) | Mean Pre Dose | 64.7 Beats per minute | Standard Deviation 8.38 |
| GSK2190915 200 mg | Assessment of Vital Signs: Heart Rate (HR) | 2 Hours, Pre Exercise | 67.2 Beats per minute | Standard Deviation 8.98 |
| GSK2190915 200 mg | Assessment of Vital Signs: Heart Rate (HR) | 9.5 Hours, Pre Exercise | 69.4 Beats per minute | Standard Deviation 9.46 |
Secondary
Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for SBP and DBP for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.
Time frame: Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period
Population: All Subjects Population was defined as all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Mean Pre Dose | 118.8 Millimeters of mercury (mmHg) | Standard Deviation 10.21 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 2 Hours, Pre Exercise | 120.1 Millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 9.5 Hours, Pre Exercise | 119.4 Millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 Hours, Pre Exercise | 117.2 Millimeters of mercury (mmHg) | Standard Deviation 11.62 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Mean Pre Dose | 71.7 Millimeters of mercury (mmHg) | Standard Deviation 7.37 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 2 Hours, Pre Exercise | 71.1 Millimeters of mercury (mmHg) | Standard Deviation 6.93 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 9.5 Hours, Pre Exercise | 71.9 Millimeters of mercury (mmHg) | Standard Deviation 6.05 |
| Placebo | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 Hours, Pre Exercise | 71.1 Millimeters of mercury (mmHg) | Standard Deviation 7.23 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 9.5 Hours, Pre Exercise | 117.0 Millimeters of mercury (mmHg) | Standard Deviation 8.69 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 2 Hours, Pre Exercise | 72.2 Millimeters of mercury (mmHg) | Standard Deviation 6.09 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Mean Pre Dose | 117.2 Millimeters of mercury (mmHg) | Standard Deviation 10.45 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 Hours, Pre Exercise | 116.9 Millimeters of mercury (mmHg) | Standard Deviation 10.73 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 2 Hours, Pre Exercise | 119.8 Millimeters of mercury (mmHg) | Standard Deviation 11.5 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 Hours, Pre Exercise | 72.0 Millimeters of mercury (mmHg) | Standard Deviation 7.84 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Mean Pre Dose | 71.9 Millimeters of mercury (mmHg) | Standard Deviation 7.4 |
| GSK2190915 10 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 9.5 Hours, Pre Exercise | 70.5 Millimeters of mercury (mmHg) | Standard Deviation 7.01 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 9.5 Hours, Pre Exercise | 72.0 Millimeters of mercury (mmHg) | Standard Deviation 7.65 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 Hours, Pre Exercise | 72.2 Millimeters of mercury (mmHg) | Standard Deviation 6.52 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 Hours, Pre Exercise | 117.4 Millimeters of mercury (mmHg) | Standard Deviation 9.93 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 2 Hours, Pre Exercise | 71.3 Millimeters of mercury (mmHg) | Standard Deviation 7.6 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 9.5 Hours, Pre Exercise | 120.5 Millimeters of mercury (mmHg) | Standard Deviation 11.37 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 2 Hours, Pre Exercise | 119.1 Millimeters of mercury (mmHg) | Standard Deviation 10.48 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Mean Pre Dose | 117.6 Millimeters of mercury (mmHg) | Standard Deviation 11.53 |
| GSK2190915 50 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Mean Pre Dose | 71.5 Millimeters of mercury (mmHg) | Standard Deviation 7.59 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 2 Hours, Pre Exercise | 119.4 Millimeters of mercury (mmHg) | Standard Deviation 10.42 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 9.5 Hours, Pre Exercise | 119.7 Millimeters of mercury (mmHg) | Standard Deviation 10.58 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 Hours, Pre Exercise | 117.5 Millimeters of mercury (mmHg) | Standard Deviation 11 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Mean Pre Dose | 71.6 Millimeters of mercury (mmHg) | Standard Deviation 6.65 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 2 Hours, Pre Exercise | 71.6 Millimeters of mercury (mmHg) | Standard Deviation 7.76 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 Hours, Pre Exercise | 71.1 Millimeters of mercury (mmHg) | Standard Deviation 8.25 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Mean Pre Dose | 117.4 Millimeters of mercury (mmHg) | Standard Deviation 11.49 |
| GSK2190915 100 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 9.5 Hours, Pre Exercise | 71.2 Millimeters of mercury (mmHg) | Standard Deviation 7.79 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 24 Hours, Pre Exercise | 119.8 Millimeters of mercury (mmHg) | Standard Deviation 11.5 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 24 Hours, Pre Exercise | 72.9 Millimeters of mercury (mmHg) | Standard Deviation 8.85 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 9.5 Hours, Pre Exercise | 118.4 Millimeters of mercury (mmHg) | Standard Deviation 11.86 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 9.5 Hours, Pre Exercise | 71.9 Millimeters of mercury (mmHg) | Standard Deviation 7.71 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Mean Pre Dose | 118.1 Millimeters of mercury (mmHg) | Standard Deviation 11.33 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, 2 Hours, Pre Exercise | 72.2 Millimeters of mercury (mmHg) | Standard Deviation 6.66 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, 2 Hours, Pre Exercise | 120.3 Millimeters of mercury (mmHg) | Standard Deviation 11.32 |
| GSK2190915 200 mg | Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Mean Pre Dose | 71.9 Millimeters of mercury (mmHg) | Standard Deviation 6.62 |
Secondary
Derived Pharmacokinetic (PK) Parameters for GSK2190915
PK samples were supposed to be collected at 10 minutes prior to the exercise challenge at 2 hours, 9.5 hours and 24 hours.
Time frame: Pre dose, 2 hours, 3.5 hours, 9.5 hours, 11 hours and 24 hours following exercise challenge of each treatment period
Population: PK Population was defined as participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed. Data was not collected for this outcome measure.
Secondary
Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose
FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100\*(FEV1 - Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at \>=80% of the predicted value for 6 minutes), the FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.
Time frame: Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period.
Population: Efficacy Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 2 Hours | -15.55 Percent change | Standard Error 1.437 |
| Placebo | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 9.5 Hours | -8.45 Percent change | Standard Error 1.222 |
| GSK2190915 10 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 2 Hours | -13.04 Percent change | Standard Error 1.424 |
| GSK2190915 10 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 9.5 Hours | -8.33 Percent change | Standard Error 1.212 |
| GSK2190915 50 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 2 Hours | -12.95 Percent change | Standard Error 1.416 |
| GSK2190915 50 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 9.5 Hours | -7.69 Percent change | Standard Error 1.206 |
| GSK2190915 100 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 9.5 Hours | -4.96 Percent change | Standard Error 1.213 |
| GSK2190915 100 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 2 Hours | -12.76 Percent change | Standard Error 1.424 |
| GSK2190915 200 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 2 Hours | -9.25 Percent change | Standard Error 1.425 |
| GSK2190915 200 mg | Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose | 9.5 Hours | -6.18 Percent change | Standard Error 1.213 |
Comparison: 2 Hours95% CI: [-0.72, 5.75]
Comparison: 9.5 Hours95% CI: [-2.34, 2.58]
Comparison: 2 Hours95% CI: [-0.64, 5.84]
Comparison: 9.5 Hours95% CI: [-1.7, 3.22]
Comparison: 2 Hours95% CI: [-0.45, 6.03]
Comparison: 9.5 Hours95% CI: [1.02, 5.95]
Comparison: 2 Hours95% CI: [3.06, 9.54]
Comparison: 9.5 Hours95% CI: [-0.19, 4.73]
Secondary
Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge
Rescue medication was provided to participants at any time and it was strongly recommended for participants with a FEV1 decrease of at least 40% following exercise challenge compared to Baseline. Rescue medication was administered 0 to 90 minutes post exercise challenge. Statistical analysis was supposed to be performed using logistic regression, however, the data was too sparse to permit any formal statistical analysis.
Time frame: 0 to 90 minutes following exercise challenge of each treatment period
Population: Efficacy Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 2 Hours | 1 Participants |
| Placebo | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 24 Hours | 0 Participants |
| Placebo | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 9.5 Hours | 1 Participants |
| GSK2190915 10 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 9.5 Hours | 0 Participants |
| GSK2190915 10 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 2 Hours | 1 Participants |
| GSK2190915 10 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 24 Hours | 0 Participants |
| GSK2190915 50 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 9.5 Hours | 0 Participants |
| GSK2190915 50 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 2 Hours | 2 Participants |
| GSK2190915 50 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 24 Hours | 0 Participants |
| GSK2190915 100 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 2 Hours | 1 Participants |
| GSK2190915 100 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 24 Hours | 0 Participants |
| GSK2190915 100 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 9.5 Hours | 0 Participants |
| GSK2190915 200 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 9.5 Hours | 0 Participants |
| GSK2190915 200 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 2 Hours | 0 Participants |
| GSK2190915 200 mg | Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge | 24 Hours | 0 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
All participants rested for at least 10 minutes in the supine position prior to ECG recordings. ECG Baseline values for each treatment period was calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours, 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours. Participants with not clinically significant (NCS) abnormal values were reported. Potential clinical importance range for the ECG parameters are as follows: absolute QTc interval \>450 millisecond (msec), increase from Baseline QTc \>60 msec, PR interval \<110 and \>220 msec and QRS interval \<75 and \>110 msec. No participants reported clinically significant abnormal values.
Time frame: Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 1, Abnormal - NCS | 15 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 24 Hours, Pre exercise, Abnormal - NCS | 16 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 9.5 Hours, Pre exercise, Abnormal - NCS | 12 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 3, Abnormal - NCS | 23 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 2, Abnormal - NCS | 17 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Pre Exercise, Abnormal - NCS | 21 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, 60 minutes, Abnormal - NCS | 15 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, 60 minutes, Abnormal - NCS | 21 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Pre Exercise, Abnormal - NCS | 22 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 2, Abnormal - NCS | 19 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 1, Abnormal - NCS | 20 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 9.5 Hours, Pre exercise, Abnormal - NCS | 18 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 3, Abnormal - NCS | 21 Participants |
| GSK2190915 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 24 Hours, Pre exercise, Abnormal - NCS | 22 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Pre Exercise, Abnormal - NCS | 15 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 1, Abnormal - NCS | 20 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 2, Abnormal - NCS | 21 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 3, Abnormal - NCS | 20 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, 60 minutes, Abnormal - NCS | 17 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 9.5 Hours, Pre exercise, Abnormal - NCS | 17 Participants |
| GSK2190915 50 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 24 Hours, Pre exercise, Abnormal - NCS | 19 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 3, Abnormal - NCS | 19 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, 60 minutes, Abnormal - NCS | 19 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 2, Abnormal - NCS | 18 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 24 Hours, Pre exercise, Abnormal - NCS | 18 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 9.5 Hours, Pre exercise, Abnormal - NCS | 16 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 1, Abnormal - NCS | 18 Participants |
| GSK2190915 100 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Pre Exercise, Abnormal - NCS | 19 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 3, Abnormal - NCS | 22 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 24 Hours, Pre exercise, Abnormal - NCS | 20 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 9.5 Hours, Pre exercise, Abnormal - NCS | 18 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, 60 minutes, Abnormal - NCS | 20 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 2, Abnormal - NCS | 21 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Pre dose 1, Abnormal - NCS | 19 Participants |
| GSK2190915 200 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 2 Hours, Pre Exercise, Abnormal - NCS | 20 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is 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, is a congenital anomaly/birth defect and medically significant.
Time frame: Up to follow up (7 to 21 days) following last dose
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 4 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2190915 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 4 Participants |
| GSK2190915 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2190915 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 4 Participants |
| GSK2190915 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2190915 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK2190915 100 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 0 Participants |
| GSK2190915 200 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 4 Participants |
| GSK2190915 200 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
Secondary
Percentage Change From Baseline in Blood Leukotriene B4 (LTB4)
Analysis LTB4 levels in the blood samples indicated the extent of LTB4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time frame: Baseline (pre dose) up to 24 Hours post dose of each treatment period
Population: Pharmacodynamics (PD) Population was defined as participants in the 'All Subjects' Population for whom a PD sample (blood or urine) was obtained and analyzed. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 2 Hours, Pre exercise | -37.32 Percent change |
| Placebo | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 24 Hours, Pre exercise | 12.59 Percent change |
| Placebo | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 9.5 Hours, Pre exercise | -14.82 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 9.5 Hours, Pre exercise | -23.43 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 2 Hours, Pre exercise | -29.32 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 24 Hours, Pre exercise | -9.56 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 9.5 Hours, Pre exercise | -87.74 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 2 Hours, Pre exercise | -87.65 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 24 Hours, Pre exercise | -84.49 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 2 Hours, Pre exercise | -97.98 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 24 Hours, Pre exercise | -70.00 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 9.5 Hours, Pre exercise | -96.53 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 9.5 Hours, Pre exercise | -99.78 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 2 Hours, Pre exercise | -98.43 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Blood Leukotriene B4 (LTB4) | 24 Hours, Pre exercise | -98.75 Percent change |
Secondary
Percentage Change From Baseline in Urine Leukotriene E4 (LTE4)
Analysis of LTE4 levels in the urine samples indicated the extent of LTE4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time frame: Baseline (pre dose) up to 24 Hours post dose of each treatment period
Population: PD Population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, 1 Hour 30 Minutes post dose | 0.96 Percent change |
| Placebo | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, Pre exercise | -0.30 Percent change |
| Placebo | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 24 Hours, Pre exercise post dose | -14.04 Percent change |
| Placebo | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, 1 Hour 30 Minutes post dose | 6.61 Percent change |
| Placebo | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, Pre exercise post dose | 0.82 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, 1 Hour 30 Minutes post dose | -45.05 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, Pre exercise post dose | -52.76 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, 1 Hour 30 Minutes post dose | -28.97 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 24 Hours, Pre exercise post dose | -29.26 Percent change |
| GSK2190915 10 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, Pre exercise | -19.68 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, Pre exercise post dose | -66.74 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, Pre exercise | -12.58 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, 1 Hour 30 Minutes post dose | -39.12 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, 1 Hour 30 Minutes post dose | -61.86 Percent change |
| GSK2190915 50 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 24 Hours, Pre exercise post dose | -70.37 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 24 Hours, Pre exercise post dose | -72.55 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, Pre exercise | -9.71 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, 1 Hour 30 Minutes post dose | -63.67 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, Pre exercise post dose | -59.85 Percent change |
| GSK2190915 100 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, 1 Hour 30 Minutes post dose | -28.67 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, Pre exercise post dose | -70.43 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 9.5 Hours, 1 Hour 30 Minutes post dose | -81.03 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, Pre exercise | -12.29 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 24 Hours, Pre exercise post dose | -77.07 Percent change |
| GSK2190915 200 mg | Percentage Change From Baseline in Urine Leukotriene E4 (LTE4) | 2 Hours, 1 Hour 30 Minutes post dose | -30.02 Percent change |
Secondary
Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge
The time from maximal percentage change in FEV1 to recovery to within 5% of pre challenge Baseline (in minutes) was derived using actual sampling times. Time to FEV1 recovery= \[SAS date/time of recovery(a) FEV1 - SAS date/time of FEV1 Maximum % Change0-60\] / 60, where a is earliest recorded FEV1 either above pre-challenge Baseline or within 5% below pre challenge Baseline. Any unscheduled FEV1 measurements taken after last scheduled post challenge measurement was considered when deriving this endpoint. A corresponding censoring variable was derived for analysis to indicate whether recovery to within 5% of pre-challenge Baseline was achieved. The censoring variable was set to 1 if recovery to within 5% of Baseline was achieved. If recovery was not evident from data collected, time to recovery was calculated using the date/time of the last available post challenge FEV1 assessment and censoring variable was set to zero. Analysis was performed using a Cox proportional hazards model.
Time frame: 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period
Population: Efficacy Population.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 2 Hours | 24.5 Minutes |
| Placebo | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 24 Hours | 5.0 Minutes |
| Placebo | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 9.5 Hours | 5.0 Minutes |
| GSK2190915 10 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 9.5 Hours | 9.0 Minutes |
| GSK2190915 10 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 2 Hours | 15.0 Minutes |
| GSK2190915 10 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 24 Hours | 0.0 Minutes |
| GSK2190915 50 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 24 Hours | 2.5 Minutes |
| GSK2190915 50 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 2 Hours | 18.0 Minutes |
| GSK2190915 50 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 9.5 Hours | 5.0 Minutes |
| GSK2190915 100 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 9.5 Hours | 0.0 Minutes |
| GSK2190915 100 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 2 Hours | 10.0 Minutes |
| GSK2190915 100 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 24 Hours | 5.0 Minutes |
| GSK2190915 200 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 9.5 Hours | 0.0 Minutes |
| GSK2190915 200 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 2 Hours | 5.0 Minutes |
| GSK2190915 200 mg | Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge | 24 Hours | 0.0 Minutes |
Comparison: 2 Hours95% CI: [0.71, 2.21]
Comparison: 9.5 Hours95% CI: [0.59, 2.06]
Comparison: 24 Hours95% CI: [0.93, 3.43]
Comparison: 2 Hours95% CI: [0.81, 2.48]
Comparison: 9.5 Hours95% CI: [1.01, 3.66]
Comparison: 24 Hours95% CI: [0.86, 3.25]
Comparison: 2 Hours95% CI: [1.19, 3.69]
Comparison: 9.5 Hours95% CI: [2.75, 10.94]
Comparison: 24 Hours95% CI: [1, 3.64]
Comparison: 2 Hours95% CI: [2, 6.48]
Comparison: 9.5 Hours95% CI: [1.07, 3.87]
Comparison: 24 Hours95% CI: [2.9, 12.71]
Secondary
Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60)
FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge.Weighted mean FEV1 percentage change recorded during 0-60 minutes post challenge was determined for each challenge, by dividing area under curve (AUC) for percent change from Baseline FEV1 measurements at 5, 10, 15, 30, 45 and 60 minutes post challenge by time interval. Actual times were used to determine time interval where available; otherwise planned relative time was used. If one or more FEV1 values were missing, AUC was calculated over time interval of available values. If intermittent values were missing over a participant's profile,it was assumed to be linear between 2 available values for calculation of AUC. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1.
Time frame: Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period.
Population: Efficacy Population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 2 Hours | -5.20 Percent change | Standard Error 0.936 |
| Placebo | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 24 Hours | -0.25 Percent change | Standard Error 0.755 |
| Placebo | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 9.5 Hours | -2.43 Percent change | Standard Error 0.757 |
| GSK2190915 10 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 9.5 Hours | -2.36 Percent change | Standard Error 0.75 |
| GSK2190915 10 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 2 Hours | -4.26 Percent change | Standard Error 0.926 |
| GSK2190915 10 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 24 Hours | 0.65 Percent change | Standard Error 0.747 |
| GSK2190915 50 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 9.5 Hours | -1.21 Percent change | Standard Error 0.745 |
| GSK2190915 50 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 2 Hours | -4.08 Percent change | Standard Error 0.92 |
| GSK2190915 50 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 24 Hours | -0.08 Percent change | Standard Error 0.742 |
| GSK2190915 100 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 2 Hours | -3.69 Percent change | Standard Error 0.926 |
| GSK2190915 100 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 24 Hours | -0.35 Percent change | Standard Error 0.747 |
| GSK2190915 100 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 9.5 Hours | 0.87 Percent change | Standard Error 0.75 |
| GSK2190915 200 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 9.5 Hours | -0.32 Percent change | Standard Error 0.75 |
| GSK2190915 200 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 2 Hours | -2.04 Percent change | Standard Error 0.927 |
| GSK2190915 200 mg | Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60) | 24 Hours | 1.46 Percent change | Standard Error 0.748 |
Comparison: 2 Hours95% CI: [-1.37, 3.25]
Comparison: 9.5 Hours95% CI: [-1.66, 1.8]
Comparison: 24 Hours95% CI: [-0.82, 2.63]
Comparison: 2 Hours95% CI: [-1.19, 3.43]
Comparison: 9.5 Hours95% CI: [-0.51, 2.95]
Comparison: 24 Hours95% CI: [-1.55, 1.9]
Comparison: 2 Hours95% CI: [-0.8, 3.82]
Comparison: 9.5 Hours95% CI: [1.57, 5.03]
Comparison: 24 Hours95% CI: [-1.83, 1.62]
Comparison: 2 Hours95% CI: [0.86, 5.48]
Comparison: 9.5 Hours95% CI: [0.38, 3.84]
Comparison: 24 Hours95% CI: [0, 3.44]