Trial Outcomes & Findings for Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03250689)
NCT ID: NCT03250689
Last Updated: 2021-03-29
Results Overview
Sputum samples were collected at indicated time points to assess NET formation via histone elastase complexes. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by 100. Analysis was performed using a mixed effect repeated measures model with covariates of treatment group, log(Baseline NETs) and treatment group by day interaction. The response variable was the log of the ratio of post-Baseline NETs to Baseline NETs. Primary completer population consisted of all participants in the Modified Intent-To-Treat population who had completed the assessments supporting the primary endpoint (sputum NETs).
TERMINATED
PHASE2
19 participants
Baseline (Day 1), Day 7 and Day 14
2021-03-29
Participant Flow
The study was conducted at single center in United Kingdom. This study was terminated early due to a change in the benefit risk profile of danirixin observed in another study NCT03034967, leading to cessation of the overall danirixin development program.
A total of 43 participants were screened, of which 23 were screen failures (23 participants did not meet inclusion/exclusion criteria). From the 20 participants who passed screening, 1 was not randomized due to study being terminated early. Hence, 19 participants were enrolled and received treatment in this study.
Participant milestones
| Measure |
Placebo
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
14
|
|
Overall Study
COMPLETED
|
5
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 6.02 • n=5 Participants
|
65.3 Years
STANDARD_DEVIATION 7.03 • n=7 Participants
|
64.3 Years
STANDARD_DEVIATION 6.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White: White/Caucasian/European Heritage
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Sputum samples were collected at indicated time points to assess NET formation via histone elastase complexes. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by 100. Analysis was performed using a mixed effect repeated measures model with covariates of treatment group, log(Baseline NETs) and treatment group by day interaction. The response variable was the log of the ratio of post-Baseline NETs to Baseline NETs. Primary completer population consisted of all participants in the Modified Intent-To-Treat population who had completed the assessments supporting the primary endpoint (sputum NETs).
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=8 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Percentage Change From Baseline in Sputum Neutrophil Extracellular Traps (NETs) Quantified by Histone-Elastase Complexes
Day 7, n=3,6
|
-3.2 Percent change
Interval -77.0 to 306.6
|
-9.4 Percent change
Interval -64.4 to 130.6
|
|
Percentage Change From Baseline in Sputum Neutrophil Extracellular Traps (NETs) Quantified by Histone-Elastase Complexes
Day 14, n=3,8
|
-30.5 Percent change
Interval -71.7 to 70.7
|
-13.6 Percent change
Interval -49.1 to 46.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Sputum samples were collected at indicated time points to assess NET formation via DNA elastase complexes. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=8 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Sputum NETs Quantified by Deoxyribonucleic Acid (DNA)-Elastase Complexes
Day 14, n=3,8
|
-4.53 Units per milliliter
Standard Error 2.696
|
2.08 Units per milliliter
Standard Error 4.072
|
|
Change From Baseline in Sputum NETs Quantified by Deoxyribonucleic Acid (DNA)-Elastase Complexes
Day 7, n=3,6
|
1.83 Units per milliliter
Standard Error 4.610
|
0.63 Units per milliliter
Standard Error 1.859
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Primary Completer Population. Only those participants with data available at the specified data points were analyzed.
Sputum samples were collected at indicated time points and NETs area was quantified by microscopy. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=7 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Percentage of Microscope Field Area Occupied by Sputum NETs
Day 7
|
NA Percentage of microscope field area
Standard Error NA
Data was not collected because 7 days treatment was insufficient to observe the changes in the sputum NETs via microscopy.
|
NA Percentage of microscope field area
Standard Error NA
Data was not collected because 7 days treatment was insufficient to observe the changes in the sputum NETs via microscopy.
|
|
Change From Baseline in Percentage of Microscope Field Area Occupied by Sputum NETs
Day 14
|
0.900 Percentage of microscope field area
Standard Error 0.9200
|
-0.259 Percentage of microscope field area
Standard Error 0.5183
|
SECONDARY outcome
Timeframe: Up to Day 21Population: Modified Intent-to-Treat Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes, Modified Intent-to-Treat Population consisted of all randomized participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
3 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Modified Intent-to-Treat Population.
SBP and DBP were measured in seated position after 5 minutes rest for the participants at indicated time points. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 7
|
-11.2 Millimeters of mercury
Standard Deviation 17.01
|
-4.1 Millimeters of mercury
Standard Deviation 17.70
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 14
|
-1.4 Millimeters of mercury
Standard Deviation 16.10
|
-5.3 Millimeters of mercury
Standard Deviation 15.77
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 7
|
-2.2 Millimeters of mercury
Standard Deviation 9.91
|
-2.1 Millimeters of mercury
Standard Deviation 10.34
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 14
|
2.6 Millimeters of mercury
Standard Deviation 11.01
|
-5.3 Millimeters of mercury
Standard Deviation 7.98
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Modified Intent-to-Treat Population.
Heart rate was measured in seated position after 5 minutes rest for the participants at indicated time points. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Heart Rate
Day 14
|
4.0 Beats per minute
Standard Deviation 6.89
|
0.1 Beats per minute
Standard Deviation 6.86
|
|
Change From Baseline in Heart Rate
Day 7
|
6.8 Beats per minute
Standard Deviation 6.02
|
1.6 Beats per minute
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Modified Intent-to-Treat Population.
Respiration rate was measured in seated position after 5 minutes rest for the participants at indicated time points. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Respiration Rate
Day 7
|
-0.6 Breaths per minute
Standard Deviation 1.95
|
1.8 Breaths per minute
Standard Deviation 2.67
|
|
Change From Baseline in Respiration Rate
Day 14
|
0.2 Breaths per minute
Standard Deviation 0.84
|
2.1 Breaths per minute
Standard Deviation 3.43
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Triplicate 12-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
PR Interval
|
7.6 Milliseconds
Standard Deviation 20.44
|
-4.8 Milliseconds
Standard Deviation 15.69
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
QRS Duration
|
-0.3 Milliseconds
Standard Deviation 1.12
|
0.5 Milliseconds
Standard Deviation 5.55
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
QT Interval
|
-4.8 Milliseconds
Standard Deviation 10.05
|
3.7 Milliseconds
Standard Deviation 15.67
|
|
Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)
QTcF Interval
|
-4.6 Milliseconds
Standard Deviation 0.38
|
-1.6 Milliseconds
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: Day 1 and Day 14Population: Modified Intent-to-Treat Population.
FEV1 is the amount of air that can be forcefully exhaled from the lungs in the first second of a forced exhalation. It was measured by spirometry test. Mean and standard deviation data of FEV1 measured at Day 1 and Day 14 have been presented.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Spirometry: Forced Expiratory Volume in One Second (FEV1) at Indicated Time Points
Day 1
|
2.458 Liter
Standard Deviation 0.6331
|
1.914 Liter
Standard Deviation 0.7267
|
|
Spirometry: Forced Expiratory Volume in One Second (FEV1) at Indicated Time Points
Day 14
|
2.344 Liter
Standard Deviation 0.7174
|
1.910 Liter
Standard Deviation 0.7428
|
SECONDARY outcome
Timeframe: Day 1 and Day 14Population: Modified Intent-to-Treat Population.
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. Mean and standard deviation data of FVC measured at Day 1 and Day 14 have been presented.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Spirometry: Forced Vital Capacity (FVC) at Indicated Time Points
Day 1
|
4.026 Liter
Standard Deviation 1.2021
|
3.416 Liter
Standard Deviation 1.1304
|
|
Spirometry: Forced Vital Capacity (FVC) at Indicated Time Points
Day 14
|
4.036 Liter
Standard Deviation 1.3992
|
3.369 Liter
Standard Deviation 1.1456
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets counts, Total neutrophils and WBC count. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Basophils
|
0.00 Giga cells per liter
Standard Deviation 0.000
|
-0.02 Giga cells per liter
Standard Deviation 0.058
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Eosinophils
|
0.040 Giga cells per liter
Standard Deviation 0.0686
|
-0.020 Giga cells per liter
Standard Deviation 0.0609
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Lymphocytes
|
-0.20 Giga cells per liter
Standard Deviation 0.316
|
-0.08 Giga cells per liter
Standard Deviation 0.269
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Monocytes
|
-0.04 Giga cells per liter
Standard Deviation 0.114
|
0.02 Giga cells per liter
Standard Deviation 0.080
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Platelets counts
|
8.2 Giga cells per liter
Standard Deviation 18.94
|
-7.9 Giga cells per liter
Standard Deviation 41.66
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
Total neutrophils
|
-0.38 Giga cells per liter
Standard Deviation 0.965
|
0.29 Giga cells per liter
Standard Deviation 0.943
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count
WBC count
|
-0.56 Giga cells per liter
Standard Deviation 0.948
|
0.16 Giga cells per liter
Standard Deviation 1.075
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
|
-0.0058 Percentage of red blood cells in blood
Standard Deviation 0.02279
|
-0.0115 Percentage of red blood cells in blood
Standard Deviation 0.02085
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
|
-2.2 Grams per liter
Standard Deviation 6.72
|
-5.4 Grams per liter
Standard Deviation 7.99
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the hematology parameter: Mean Corpuscular Volume. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume
|
0.06 Femtoliter
Standard Deviation 1.339
|
0.31 Femtoliter
Standard Deviation 1.263
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the hematology parameter: Mean Corpuscular Hemoglobin. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin
|
-0.08 Picograms
Standard Deviation 0.920
|
-0.22 Picograms
Standard Deviation 0.749
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the hematology parameter: Red Blood Cell count. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Hematology Parameter: Red Blood Cell Count
|
-0.070 Trillion cells per liter
Standard Deviation 0.2081
|
-0.154 Trillion cells per liter
Standard Deviation 0.2171
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
ALT
|
-1.6 International units per liter
Standard Deviation 4.39
|
-1.9 International units per liter
Standard Deviation 8.24
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
ALP
|
2.8 International units per liter
Standard Deviation 6.26
|
1.3 International units per liter
Standard Deviation 13.89
|
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)
AST
|
-0.6 International units per liter
Standard Deviation 2.61
|
-3.1 International units per liter
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the chemistry parameters: Calcium, Glucose, Potassium, Sodium and Urea. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Glucose
|
0.36 Millimoles per liter
Standard Deviation 0.635
|
0.12 Millimoles per liter
Standard Deviation 0.398
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Urea
|
-0.42 Millimoles per liter
Standard Deviation 0.867
|
0.26 Millimoles per liter
Standard Deviation 0.777
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Calcium
|
-0.032 Millimoles per liter
Standard Deviation 0.0782
|
-0.034 Millimoles per liter
Standard Deviation 0.0947
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Potassium
|
-0.12 Millimoles per liter
Standard Deviation 0.148
|
0.06 Millimoles per liter
Standard Deviation 0.287
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea
Sodium
|
0.0 Millimoles per liter
Standard Deviation 1.58
|
0.2 Millimoles per liter
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Blood samples were collected to analyze the chemistry parameters: Creatinine, Direct Bilirubin and Total Bilirubin. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin
Creatinine
|
2.6 Micromoles per liter
Standard Deviation 5.86
|
1.2 Micromoles per liter
Standard Deviation 6.99
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin
Direct Bilirubin
|
-0.4 Micromoles per liter
Standard Deviation 0.55
|
0.7 Micromoles per liter
Standard Deviation 1.65
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin
Total Bilirubin
|
0.8 Micromoles per liter
Standard Deviation 0.84
|
-1.2 Micromoles per liter
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Urinary specific gravity measurement is a part of routine urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Specific Gravity
|
0.0030 Unitless
Standard Deviation 0.00908
|
0.0046 Unitless
Standard Deviation 0.00887
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)
|
1.00 pH
Standard Deviation 1.225
|
-0.25 pH
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Sputum samples were collected at indicated time points to analyze resistin levels. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=8 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Sputum Resistin Levels
Day 14, n=3,8
|
15.28 Nanograms per milliliter
Standard Error 27.619
|
2.61 Nanograms per milliliter
Standard Error 2.711
|
|
Change From Baseline in Sputum Resistin Levels
Day 7, n=3,6
|
8.93 Nanograms per milliliter
Standard Error 15.513
|
-2.01 Nanograms per milliliter
Standard Error 4.629
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Primary Completer Population. Only those participants with data available at the specified data points were analyzed.
Sputum samples were collected to calculate ratio of sputum NETs to sputum neutrophils. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value. The ratio is calculated as the sputum NETs divided by the number of sputum neutrophils.
Outcome measures
| Measure |
Placebo
n=2 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=7 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in the Ratio of Sputum NETs to Sputum Neutrophils
|
0.5200 Ratio
Standard Error 0.41000
|
0.4557 Ratio
Standard Error 0.53149
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Sputum samples were collected at indicated time points to analyze sputum elastase activity. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=8 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Sputum Elastase Activity
Day 7, n=3,6
|
638.0 Nanograms per milliliter
Standard Error 381.36
|
238.0 Nanograms per milliliter
Standard Error 224.50
|
|
Change From Baseline in Sputum Elastase Activity
Day 14, n=3,8
|
411.3 Nanograms per milliliter
Standard Error 439.20
|
66.1 Nanograms per milliliter
Standard Error 45.64
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points to analyze peripheral blood neutrophil NETs formation by DNA release. DNA-elastase complexes quantified NETs formation. Phorbol 12-myristate 13-acetate (PMA) was used to induce inflammation and NETs formation in the PMA stimulated samples. Blood from participants were tested at Baseline and Day 14 for non-PMA stimulated samples, and at Baseline and Day 14 in PMA-stimulated samples to test whether treatment had any effect on NETs formation either naturally (non PMA induced) or where NETs formation was already raised (PMA stimulated). Hence participants were counted in both the categories - PMA stimulated and not PMA stimulated. NETs formation in peripheral blood was measured with SYTOX green fluorescence quantification of extracellular DNA. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
Placebo
n=5 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=12 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by DNA Release
Not PMA stimulated
|
3044.8 Relative fluorescence units
Standard Error 4251.78
|
-721.1 Relative fluorescence units
Standard Error 731.82
|
|
Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by DNA Release
PMA stimulated
|
-96.8 Relative fluorescence units
Standard Error 9418.43
|
-1211.0 Relative fluorescence units
Standard Error 5102.21
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 14Population: Modified Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points to analyze peripheral blood neutrophil NETs formation by microscopy.DNA-elastase complexes quantified NETs formation.PMA was used to induce inflammation and NETs formation in PMA stimulated samples. Blood from participants were tested at Baseline and Day14 for non-PMA stimulated samples,and at Baseline and Day14 in PMA-stimulated samples to test whether treatment had any effect on NETs formation either naturally(non PMA induced)or where NETs formation was already raised(PMA stimulated).Participants were counted in both categories-PMA stimulated and not PMA stimulated.NETs formation in peripheral blood was measured with SYTOX green fluorescence quantification of extracellular DNA.Baseline was considered as Day1.Change from Baseline was calculated as post-Baseline value minus Baseline value.Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by100.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=11 Participants
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Percentage Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by Microscopy
Not PMA stimulated
|
927.5 Percent change
Standard Error 585.03
|
560.5 Percent change
Standard Error 395.72
|
|
Percentage Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by Microscopy
PMA stimulated
|
44.7 Percent change
Standard Error 41.79
|
90.6 Percent change
Standard Error 60.33
|
SECONDARY outcome
Timeframe: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the pharmacokinetic (PK) of danirixin at the indicated time points for the analysis of Cmax. PK population consisted of all participants in the Modified Intent-To-Treat population who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values).
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Danirixin
Day 1, n=14
|
855.2 Nanograms per milliliter
Geometric Coefficient of Variation 52.29
|
—
|
|
Maximum Observed Concentration (Cmax) of Danirixin
Day 14, n=13
|
1135.2 Nanograms per milliliter
Geometric Coefficient of Variation 65.73
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tmax.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Time to Cmax (Tmax) of Danirixin
Day 1, n=14
|
1.000 Hours
Interval 0.5 to 4.0
|
—
|
|
Time to Cmax (Tmax) of Danirixin
Day 14, n=13
|
1.000 Hours
Interval 0.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of AUC(0-t).
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Area Under the Blood Concentration-time Curve [AUC(0-t)] of Danirixin
Day 1
|
2173.4 Hours * nanograms per milliliter
Geometric Coefficient of Variation 39.57
|
—
|
|
Area Under the Blood Concentration-time Curve [AUC(0-t)] of Danirixin
Day 14
|
2751.1 Hours * nanograms per milliliter
Geometric Coefficient of Variation 51.24
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tlast.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Time of Last Observed Concentration (Tlast) of Danirixin
Day 14, n=13
|
4.000 Hours
Interval 4.0 to 4.0
|
—
|
|
Time of Last Observed Concentration (Tlast) of Danirixin
Day 1, n=14
|
4.000 Hours
Interval 4.0 to 4.05
|
—
|
Adverse Events
Placebo
Danirixin Hydrobromide 35 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=5 participants at risk
Participants received one tablet of matching placebo twice daily orally with food for 14 days.
|
Danirixin Hydrobromide 35 mg
n=14 participants at risk
Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Malaise
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/5 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 1 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/14 • AEs and SAEs were collected from start of the treatment up to Day 21
AEs and SAEs were collected for modified Intent-to-Treat Population which consisted of all randomized participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER