| Primary | Percentage Change From Baseline in Sputum Neutrophil Extracellular Traps (NETs) Quantified by Histone-Elastase Complexes | 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). | Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Percent change | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
| | | Title | Denominators | Categories |
|---|
| Day 7, n=3,6 | - ParticipantsOG0003
- ParticipantsOG0016
| | Title | Measurements |
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| - OG000-3.2(-77.0 to 306.6)
|
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| Secondary | Change From Baseline in Sputum NETs Quantified by Deoxyribonucleic Acid (DNA)-Elastase Complexes | 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. | Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | Units per milliliter | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Percentage of Microscope Field Area Occupied by Sputum NETs | 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. | Primary Completer Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Error | Percentage of microscope field area | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | Modified Intent-to-Treat Population. | Posted | | Count of Participants | | Participants | | Up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Heart Rate | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Respiration Rate | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Milliseconds | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Spirometry: Forced Expiratory Volume in One Second (FEV1) at Indicated Time Points | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Liter | | Day 1 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Spirometry: Forced Vital Capacity (FVC) at Indicated Time Points | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Liter | | Day 1 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Giga cells per liter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Hematology Parameter: Hemoglobin | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Volume | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Picograms | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Hematology Parameter: Red Blood Cell Count | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Trillion cells per liter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Urinalysis Parameter: Specific Gravity | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | Unitless | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH) | 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. | Modified Intent-to-Treat Population. | Posted | | Mean | Standard Deviation | pH | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Sputum Resistin Levels | 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. | Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | Nanograms per milliliter | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in the Ratio of Sputum NETs to Sputum Neutrophils | 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. | Primary Completer Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Error | Ratio | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Sputum Elastase Activity | 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. | Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | Nanograms per milliliter | | Baseline (Day 1), Day 7 and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by DNA Release | 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. | Modified Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Error | Relative fluorescence units | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Percentage Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by Microscopy | 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. | Modified Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Error | Percent change | | Baseline (Day 1) and Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received one tablet of matching placebo twice daily orally with food for 14 days. | | OG001 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Maximum Observed Concentration (Cmax) of Danirixin | 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). | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Time to Cmax (Tmax) of Danirixin | Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tmax. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Median | Full Range | Hours | | Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Area Under the Blood Concentration-time Curve [AUC(0-t)] of Danirixin | Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of AUC(0-t). | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours * nanograms per milliliter | | Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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| Secondary | Time of Last Observed Concentration (Tlast) of Danirixin | Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tlast. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Median | Full Range | Hours | | Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Danirixin Hydrobromide 35 mg | Participants received one tablet of danirixin hydrobromide 35 milligram (mg) twice daily orally with food for 14 days. |
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