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This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate safety, tolerability, pharmacokinetics and serum cortisol levels.
This study will investigate the effect of dosing with fluticasone furoate 100 μg (micrograms) in asthmatic subjects aged 5-11 years of age. Fluticasone furoate is currently under development as the inhaled corticosteroid component of a combination product containing an inhaled corticosteroid and a long-acting beta-agonist.
The study will be a randomized two-way crossover, with a placebo control. During each treatment period subjects will receive a daily dose via a novel dry powder inhaler for 14 days. Approximately 26 subjects will be recruited to this study, with the aim that 20 will complete the study. Safety, tolerability, pharmacokinetics and serum cortisol levels will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COHORT 1 RANDOMISATION A | Active Comparator | (8-11 years old) Repeat dose session: Fluticasone furoate 100µg; Day 1 and Day 14 = in house dosing; Day 2-13 = home dosing |
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| COHORT 1 RANDOMISATION B | Placebo Comparator | (8-11 years old) Repeat dose session: matching placebo; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing |
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| COHORT 2 RANDOMISATION A | Active Comparator | (5-7 years old) Repeat dose session: Fluticasone furoate 100µg; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing |
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| COHORT 2 RANDOMISATION B | Placebo Comparator | (5-7 years old) Repeat dose session: Matching placebo; Day 1 and Day 14 = in house dosing; Days 2-13 = home dosing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone furoate | Drug | Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. | From the start of study medication until Week 11 (Visit 6)/Early Withdrawal |
| Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) on Day 14 of the Respective Treatment Period | Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cypress | California | 90630 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 102942 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A Baseline assessment was carried out on Day 1 of the first treatment period. Participants were then randomized to one of the two possible treatment sequences (fluticasone furoate [FF] 100 µg followed by placebo; placebo followed by FF 100 µg). Results are reported by intervention, regardless of the age of the participant.
Participants were enrolled into one of two cohorts based upon age; the younger cohort was enrolled after a review of the safety/pharmacokinetic data of at least six participants from the older cohort. Each participant was assigned to treatment randomly; assignment was not to be influenced by whether participants were in Cohort 1 or Cohort 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: FF 100 µg Followed by Placebo | Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days. |
| FG001 | Sequence 2: Placebo Followed by FF 100 µg | Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Treatment Period 1 (14 Days) |
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| Treatment Period 2 (14 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | FF 100 µg/Placebo or Placebo/FF 100 µg | Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs. | All Subjects Population: all participants who received at least one dose of study medication | Posted | Number | participants | From the start of study medication until Week 11 (Visit 6)/Early Withdrawal |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
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| Matching placebo | Drug | Novel dry powder inhaler: One blister strip containing lactose and a second blister strip containing lactose and magnesium stearate. |
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| Hematocrit Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). | Day 14 of the respective treatment period (up to Study Day 44) |
| Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Albumin and Total Protein Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. | Day 14 of the respective treatment period (up to Study Day 44) |
| Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period | Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period. | Day 1 and Day 14 of the respective treatment period (up to Study Day 44) |
| Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period | SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. | Baseline and Day 14 of the respective treatment period (up to Study Day 44) |
| Heart Rate at Baseline and Day 14 of the Respective Treatment Period | Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. | Baseline and Day 14 of the respective treatment period (up to Study Day 44) |
| Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period | PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett's formula. QTcF is the QT duration corrected for heart rate by Fridericia's formula. | Baseline and Day 14 of the respective treatment period (up to Study Day 44) |
| Day 14 of the respective treatment period |
| Cmax on Day 14 of the Respective Treatment Period | Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. | Day 14 of the respective treatment period |
| Tmax and t at Day 14 of the Respective Treatment Period | tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. | Day 14 of the respective treatment period |
| Serum Cortisol Weighted Mean (0-12 Hours) on Day 14 of the Respective Treatment Period | Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. | Day 14 of the respective treatment period |
| Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period | During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated. | Days 1 and 14 of the respective treatment period |
| Distance of Assessment on Days 1 and 14 of the Respective Treatment Period | During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated. | Days 1 and 14 of the respective treatment period |
| Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period | During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated. | Days 1 and 14 of the respective treatment period |
| Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. | Day 1 and Day 14 of the respective treatment period |
| Inhalation Time on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. | Day 1 and Day 14 of the respective treatment period |
| Inhaled Volume on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. | Day 1 and Day 14 of the respective treatment period |
| Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. | Day 1 and Day 14 of the respective treatment period |
| Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period | The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose. | Day 1 and Day 14 of the respective treatment period |
| Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period | The ex-throat dose (ETD) and the "nominal ETD" is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns. | Day 1 and Day 14 of the respective treatment period |
| Huntington Beach |
| California |
| 92647 |
| United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Normal | Illinois | 61761 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 102942 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102942 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102942 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102942 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102942 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 102942 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Placebo |
All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days. |
| OG001 | FF 100 µg | All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days. |
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| Primary | Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter (GI/L) | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | 10^12 cells per liter (TI/L) | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Hematocrit Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). | All Subjects Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | percentage of red blood cells in blood | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed . | Posted | Mean | Standard Deviation | 10^15 femtoliters (fL) per cell | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 picograms (pg) per cell | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Albumin and Total Protein Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Grams per liter | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period | Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Micromoles per liter (µmol/L) | Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period | Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period. | All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | liters/minute | Day 1 and Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period | SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline and Day 14 of the respective treatment period (up to Study Day 44) |
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| Primary | Heart Rate at Baseline and Day 14 of the Respective Treatment Period | Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline and Day 14 of the respective treatment period (up to Study Day 44) |
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| Secondary | AUC(0-t) on Day 14 of the Respective Treatment Period | Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12). | Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzed | Posted | Geometric Mean | 95% Confidence Interval | picograms*hour per milliliter (pg*hr/mL) | Day 14 of the respective treatment period |
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| Secondary | Cmax on Day 14 of the Respective Treatment Period | Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. | PK Population | Posted | Geometric Mean | 95% Confidence Interval | picograms per milliliter (pg/mL) | Day 14 of the respective treatment period |
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| Secondary | Tmax and t at Day 14 of the Respective Treatment Period | tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. | PK Population. Only those participant who had quantifiable FF concentrations were analyzed. | Posted | Mean | Standard Deviation | hours | Day 14 of the respective treatment period |
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| Secondary | Serum Cortisol Weighted Mean (0-12 Hours) on Day 14 of the Respective Treatment Period | Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. | All Subjects Population. Only those participants available at the specified time point were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | nanomoles per Liter | Day 14 of the respective treatment period |
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| Secondary | Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period | During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | centimeters squared (cm^2) | Days 1 and 14 of the respective treatment period |
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| Secondary | Distance of Assessment on Days 1 and 14 of the Respective Treatment Period | During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | centimeters (cm) | Days 1 and 14 of the respective treatment period |
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| Secondary | Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period | During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | cubic centimeters (cm^3) | Days 1 and 14 of the respective treatment period |
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| Secondary | Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Liters per minute (L/min) | Day 1 and Day 14 of the respective treatment period |
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| Secondary | Inhalation Time on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Seconds | Day 1 and Day 14 of the respective treatment period |
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| Secondary | Inhaled Volume on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Liters | Day 1 and Day 14 of the respective treatment period |
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| Secondary | Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period | During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | Kilopascal (kpa) | Day 1 and Day 14 of the respective treatment period |
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| Secondary | Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period | The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | micrograms | Day 1 and Day 14 of the respective treatment period |
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| Secondary | Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period | The ex-throat dose (ETD) and the "nominal ETD" is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | micrograms | Day 1 and Day 14 of the respective treatment period |
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| Primary | Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period | PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett's formula. QTcF is the QT duration corrected for heart rate by Fridericia's formula. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline and Day 14 of the respective treatment period (up to Study Day 44) |
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| 0 |
| 25 |
| 4 |
| 25 |
| EG001 | FF 100 µg | All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days. | 0 | 26 | 8 | 26 |
| Acute tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Product taste abnormal | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Lymphocytes, n=23, 21 |
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| Monocytes, n=23, 21 |
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| Total neutrophils, n=23, 21 |
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| Platelets, n=23, 20 |
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| WBCs, n=23, 21 |
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| AST, n=22, 19 |
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| GGT, n=22, 20 |
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| CO2 content/bicarbonate, n=20, 19 |
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| Glucose, n=22, 20 |
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| Potassium, n=20, 19 |
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| Sodium, n=22, 20 |
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| Urea/BUN, n=22, 20 |
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| Uric acid, n= 22, 20 |
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| Day 1, 30 minutes post-dose, n=25, 25 |
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| Day 1, 1 hour post-dose, n=25, 25 |
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| Day 1, 2 hours post-dose, n=25, 25 |
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| Day 14, Pre-dose, n=24, 23 |
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| Day 14, 30 minutes post-dose, n=23, 23 |
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| Day 14, 1 hours post-dose, n=23, 23 |
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| Day 14, 2 hours post-dose, n=23, 23 |
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| Day 14, 4 hours post-dose, n=23, 23 |
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| Day 14, 7 hours post-dose, n=23, 23 |
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| Day 14, 12 hours post-dose, n=23, 23 |
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| Day 1 SBP, 1 hour, n=25, 26 |
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| Day 1 SBP, 2 hours, n=25, 26 |
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| Day 14 SBP, Predose, n=24, 23 |
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| Day 14 SBP, 1 hour, n=23, 23 |
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| Day 14 SBP, 4 hours, n=23, 23 |
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| Day 14 SBP, 7 hours, n=23, 23 |
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| Day 14 SBP, 12 hours, n=23, 23 |
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| Day 1 DBP, Predose, n=25, 26 |
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| Day 1 DBP, 30 minutes, n=25, 26 |
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| Day 1 DBP, 1 hour, n=25, 26 |
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| Day 1 DBP, 2 hours, n=25, 26 |
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| Day 14 DBP, Predose, n=24, 23 |
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| Day 14 DBP, 1 hour, n=23, 23 |
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| Day 14 DBP, 4 hours, n=23, 23 |
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| Day 14 DBP, 7 hours, n=23, 23 |
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| Day 14 DBP, 12 hours, n=23, 23 |
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| Day 1, 1 hour, n=25, 26 |
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| Day 1, 2 hours, n=25, 26 |
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| Day 14, Predose, n=24, 23 |
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| Day 14, 1 hour, n=23, 23 |
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| Day 14, 4 hours, n=23, 23 |
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| Day 14, 7 hours, n=23, 23 |
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| Day 14, 12 hours, n=23, 23 |
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| Day 1 PIFR, n=21, 20 |
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| Day 14 PIFR, n=21, 22 |
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| Title | Measurements |
|---|---|
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| Day 14, Minimum TED, n=0, 22 |
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| Day 1, Maximum TED, n=0, 20 |
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| Day 14, Maximum TED, n=0, 22 |
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| Title | Measurements |
|---|---|
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| Day 14, Minimum ETD, n=0, 12 |
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| Day 1, Maximum ETD, n=0, 17 |
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| Day 14, Maximum ETD, n=0, 12 |
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| Day 1, ETD <2 microns, n=0, 17 |
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| Day 14, ETD <2 microns, n=0, 12 |
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| Day 1, Minimum ETD <2 microns, n=0, 17 |
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| Day 14, Minimum ETD <2 microns, n=0, 12 |
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| Day 1, Maximum ETD <2 microns, n=0, 17 |
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| Day 14, Maximum ETD <2 microns, n=0, 12 |
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| Day 1 PR Interval, 2 hours, n=25, 26 |
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| Day 14 PR Interval, Predose, n=24, 23 |
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| Day 14 PR Interval, 1 hour, n=23, 23 |
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| Day 14 PR Interval, 4 hours, n=23, 23 |
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| Day 14 PR Interval, 7 hour, n=23, 23 |
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| Day 14 PR Interval, 12 hours, n=22, 23 |
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| Day 1 QRS Interval, 30 minutes, n=25, 26 |
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| Day 1 QRS Interval, 1 hour, n=25, 26 |
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| Day 1 QRS Interval, 2 hours, n=25, 26 |
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| Day 14 QRS Interval, Predose, n=24, 23 |
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| Day 14 QRS Interval, 1 hour, n=23, 23 |
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| Day 14 QRS Interval, 4 hours, n=23, 23 |
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| Day 14 QRS Interval, 7 hours, n=23, 23 |
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| Day 14 QRS Interval, 12 hours, n=23, 23 |
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| Day 1 QT Interval, 30 minutes, n=25, 26 |
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| Day 1 QT Interval, 1 hour, n=25, 26 |
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| Day 1 QT Interval, 2 hours, n=25, 26 |
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| Day 14 QT Interval, Predose, n=24, 23 |
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| Day 14 QT Interval, 1 hour, n=23, 23 |
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| Day 14 QT Interval, 4 hours, n=23, 23 |
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| Day 14 QT Interval, 7 hours, n=23, 23 |
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| Day 14 QT Interval, 12 hours, n=23, 23 |
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| Day 1 QTcB Interval, 30 minutes, n=25, 26 |
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| Day 1 QTcB Interval, 1 hour, n=25, 26 |
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| Day 1 QTcB Interval, 2 hours, n=25, 26 |
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| Day 14 QTcB Interval, Predose, n=24, 23 |
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| Day 14 QTcB Interval, 1 hour, n=23, 23 |
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| Day 14 QTcB Interval, 4 hours, n=23, 23 |
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| Day 14 QTcB Interval, 7 hours, n=23, 23 |
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| Day 14 QTcB Interval, 12 hours, n=23, 23 |
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| Day 1 QTcF Interval, 30 minutes, n=25, 26 |
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| Day 1 QTcF Interval, 1 hour, n=25, 26 |
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| Day 1 QTcF Interval, 2 hours, n=25, 26 |
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| Day 14 QTcF Interval, Predose, n=24, 23 |
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| Day 14 QTcF Interval, 1 hour, n=23, 23 |
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| Day 14 QTcF Interval, 4 hours, n=23, 23 |
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| Day 14 QTcF Interval, 7 hours, n=23, 23 |
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| Day 14 QTcF Interval, 12 hours, n=23, 23 |
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| Day 1 RR Interval, 30 minutes, n=25, 26 |
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| Day 1 RR Interval, 1 hour, n=25, 26 |
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| Day 1 RR Interval, 2 hours, n=25, 26 |
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| Day 14 RR Interval, Predose, n=24, 23 |
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| Day 14 RR Interval, 1 hour, n=23, 23 |
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| Day 14 RR Interval, 4 hours, n=23, 23 |
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| Day 14 RR Interval, 7 hours, n=23, 23 |
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| Day 14 RR Interval, 12 hours, n=23, 23 |
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