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Trial record 96 of 118 for:    oseltamivir

Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza

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ClinicalTrials.gov Identifier: NCT02469298
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : August 24, 2017
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Virus Diseases
Interventions Drug: GSK1325756 (Danirixin)
Drug: Placebo To Match GSK1325756
Drug: Oseltamivir Phosphate
Drug: Placebo To Match Oseltamivir Phosphate
Enrollment 45
Recruitment Details A total of 45 healthy adult participants with acute, uncomplicated influenza were enrolled. The study was conducted from 01-June 2015 to 25-April-2016 at 17 centres in 3 countries.
Pre-assignment Details A total of 288 participants were screened for this study. Of these, 243 participants were screen failures and 45 were randomized. The reasons for screen failure included: not meeting inclusion/exclusion criteria (238 participants), lost to follow up (1 participant), investigator discretion (1 participant) and withdrew consent (43 participants).
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Period Title: Overall Study
Started 15 7 16 7
Completed 14 6 14 5
Not Completed 1 1 2 2
Reason Not Completed
Protocol Violation             0             1             1             0
Lost to Follow-up             1             0             1             0
Physician Decision             0             0             0             1
Withdrawal by Subject             0             0             0             1
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg Total
Hide Arm/Group Description Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days Total of all reporting groups
Overall Number of Baseline Participants 15 7 16 7 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 7 participants 16 participants 7 participants 45 participants
37.9  (13.40) 33.4  (11.56) 42.6  (11.53) 36.3  (9.83) 38.6  (12.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 7 participants 16 participants 7 participants 45 participants
Female
6
  40.0%
1
  14.3%
7
  43.8%
2
  28.6%
16
  35.6%
Male
9
  60.0%
6
  85.7%
9
  56.3%
5
  71.4%
29
  64.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 7 participants 16 participants 7 participants 45 participants
African American/African Heritage 2 0 1 1 4
American Indian or Alaskan Native 1 0 0 0 1
Asian - Central/South Asian Heritage 0 2 0 0 2
Asian - East Asian Heritage 0 0 1 0 1
Native Hawaiian or other Pacific Islander 1 0 0 0 1
White - White/Caucasian/European Heritage 11 5 13 6 35
Mixed Race 0 0 1 0 1
1.Primary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Measure Type: Count of Participants
Unit of Measure: Participants
AE
3
  20.0%
4
  57.1%
7
  43.8%
0
   0.0%
SAE
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count
Hide Description Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Giga cells per litre (GI/L)
Basophils: Day 3 Number Analyzed 14 participants 5 participants 12 participants 5 participants
-0.011  (0.0511) -0.002  (0.0377) -0.008  (0.0196) -0.008  (0.0130)
Basophils: Day 5 Number Analyzed 14 participants 6 participants 12 participants 5 participants
-0.009  (0.0569) 0.017  (0.0427) -0.007  (0.0172) -0.002  (0.0110)
Basophils: Day 8 Number Analyzed 14 participants 6 participants 13 participants 5 participants
-0.008  (0.0634) 0.013  (0.0356) 0.005  (0.0190) 0.008  (0.0311)
Basophils: Day 28/withdrawal Number Analyzed 14 participants 7 participants 11 participants 5 participants
-0.007  (0.0517) 0.003  (0.0287) 0.030  (0.0520) 0.010  (0.0332)
Eosinophils: Day 3 Number Analyzed 14 participants 5 participants 12 participants 5 participants
0.017  (0.0929) 0.026  (0.0477) -0.012  (0.1378) -0.012  (0.0661)
Eosinophils: Day 5 Number Analyzed 14 participants 6 participants 12 participants 5 participants
0.034  (0.1048) 0.035  (0.0846) 0.012  (0.1856) 0.136  (0.3057)
Eosinophils: Day 8 Number Analyzed 14 participants 6 participants 13 participants 5 participants
0.074  (0.1248) 0.078  (0.1332) 0.036  (0.1416) -0.000  (0.0959)
Eosinophils: Day 28/withdrawal Number Analyzed 14 participants 7 participants 11 participants 5 participants
0.030  (0.1335) 0.163  (0.2016) 0.032  (0.1432) -0.018  (0.0487)
Lymphocytes: Day 3 Number Analyzed 14 participants 5 participants 12 participants 5 participants
0.093  (0.6701) 0.778  (0.5904) 0.463  (0.5443) 0.432  (0.5124)
Lymphocytes: Day 5 Number Analyzed 14 participants 6 participants 12 participants 5 participants
0.557  (0.7137) 1.038  (0.7784) 0.813  (0.6445) 0.576  (0.3765)
Lymphocytes: Day 8 Number Analyzed 14 participants 6 participants 13 participants 5 participants
0.716  (0.7584) 1.275  (0.8948) 0.918  (0.9233) 0.722  (0.5434)
Lymphocytes: Day 28/withdrawal Number Analyzed 14 participants 7 participants 11 participants 5 participants
0.564  (0.5969) 1.619  (0.7884) 0.903  (0.6779) 0.788  (0.4467)
Monocytes: Day 3 Number Analyzed 14 participants 5 participants 12 participants 5 participants
-0.117  (0.1524) -0.178  (0.1970) -0.105  (0.1927) -0.070  (0.1562)
Monocytes: Day 5 Number Analyzed 14 participants 6 participants 12 participants 5 participants
-0.175  (0.2817) -0.128  (0.1631) -0.090  (0.2479) -0.118  (0.2104)
Monocytes: Day 8 Number Analyzed 14 participants 6 participants 13 participants 5 participants
-0.104  (0.2310) -0.097  (0.1425) -0.108  (0.2043) 0.024  (0.1730)
Monocytes: Day 28/withdrawal Number Analyzed 14 participants 7 participants 11 participants 5 participants
-0.061  (0.1785) -0.011  (0.2230) -0.016  (0.2232) 0.064  (0.1343)
Total neutrophils: Day 3 Number Analyzed 14 participants 5 participants 12 participants 5 participants
-1.614  (2.1846) -2.276  (1.5252) -1.791  (1.9580) -0.416  (1.0604)
Total neutrophils: Day 5 Number Analyzed 14 participants 6 participants 12 participants 5 participants
-1.371  (2.1110) -1.223  (2.2278) -0.677  (1.6269) -0.424  (0.7956)
Total neutrophils: Day 8 Number Analyzed 14 participants 6 participants 13 participants 5 participants
0.463  (2.0336) -0.830  (2.0826) -0.137  (2.4279) 1.766  (2.4391)
Total neutrophils:Day 28/withdrawal Number Analyzed 14 participants 7 participants 11 participants 5 participants
-0.217  (2.2068) -0.217  (2.0710) -0.381  (2.1920) 0.970  (1.8349)
Platelet count: Day 3 Number Analyzed 13 participants 6 participants 14 participants 5 participants
-9.5  (16.13) 4.3  (17.68) -6.1  (17.68) -3.0  (16.08)
Platelet count: Day 5 Number Analyzed 14 participants 6 participants 14 participants 5 participants
16.4  (22.92) 6.7  (21.70) 13.7  (31.50) 10.4  (17.78)
Platelet count: Day 8 Number Analyzed 14 participants 7 participants 13 participants 5 participants
64.3  (45.02) 62.1  (58.12) 53.3  (61.73) 66.2  (22.20)
Platelet count: Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
28.3  (38.74) 47.7  (40.13) 19.2  (42.67) 44.2  (8.76)
WBC count: Day 3 Number Analyzed 14 participants 5 participants 14 participants 5 participants
-1.62  (1.949) -1.64  (0.879) -1.49  (1.624) -0.06  (0.691)
WBC count: Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.94  (2.408) -0.39  (1.676) -0.17  (1.618) 0.18  (1.221)
WBC count: Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
1.14  (2.676) 0.49  (1.842) 0.79  (2.309) 2.52  (2.797)
WBC count: Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
0.31  (2.310) 1.56  (1.992) 0.51  (2.250) 1.76  (1.696)
3.Primary Outcome
Title Change From Baseline in Hematology Parameters- Hemoglobin
Hide Description Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Grams per Litre (G/L)
Day 3 Number Analyzed 14 participants 6 participants 14 participants 5 participants
0.0  (6.08) 2.2  (5.78) -4.4  (6.87) -8.8  (9.78)
Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-1.3  (6.37) 0.4  (4.96) -5.9  (10.87) -7.4  (11.28)
Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-5.2  (6.27) -0.6  (4.65) -6.1  (11.65) -7.0  (13.77)
Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
-5.9  (9.61) -5.1  (4.49) -10.1  (7.83) -4.4  (12.14)
4.Primary Outcome
Title Change From Baseline in Hematology Parameters- Hematocrit
Hide Description Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Fraction
Day 3 Number Analyzed 14 participants 6 participants 14 participants 5 participants
-0.0051  (0.01940) 0.0050  (0.01917) -0.0126  (0.02310) -0.0294  (0.03218)
Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.0056  (0.01917) -0.0029  (0.01734) -0.0182  (0.03470) -0.0250  (0.03033)
Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.0173  (0.01958) -0.0063  (0.01612) -0.0176  (0.03636) -0.0244  (0.04140)
Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
-0.0224  (0.02773) -0.0171  (0.01933) -0.0331  (0.02586) -0.0136  (0.03978)
5.Primary Outcome
Title Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
Hide Description Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Picogram (PG)
Day 3 Number Analyzed 14 participants 6 participants 14 participants 5 participants
0.03  (0.334) -0.23  (0.242) -0.21  (0.218) 0.06  (0.329)
Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.11  (0.407) -0.19  (0.121) -0.14  (0.609) 0.02  (0.455)
Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.16  (0.363) -0.13  (0.198) -0.24  (0.477) 0.08  (0.277)
Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
0.12  (0.638) -0.00  (0.231) 0.18  (0.479) 0.20  (0.381)
6.Primary Outcome
Title Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
Hide Description Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Femtoliters (FL)
Day 3 Number Analyzed 14 participants 6 participants 14 participants 5 participants
-0.9  (1.38) -0.8  (1.17) -0.4  (1.70) -0.2  (0.84)
Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.7  (1.20) -1.3  (1.50) -0.4  (0.85) -0.2  (0.84)
Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.6  (1.55) -1.1  (1.07) -0.5  (1.02) -0.4  (1.14)
Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
-0.4  (2.06) -0.3  (2.06) 0.1  (1.04) 0.6  (0.55)
7.Primary Outcome
Title Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count
Hide Description Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Trillion cells per Liter (TI/L)
RBC: Day 3 Number Analyzed 14 participants 6 participants 14 participants 5 participants
-0.01  (0.209) 0.13  (0.197) -0.11  (0.235) -0.32  (0.370)
RBC: Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.01  (0.203) 0.06  (0.190) -0.19  (0.390) -0.28  (0.363)
RBC: Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.13  (0.194) 0.01  (0.146) -0.17  (0.389) -0.28  (0.476)
RBC: Day 28/withdrawal Number Analyzed 14 participants 7 participants 13 participants 5 participants
-0.22  (0.272) -0.16  (0.113) -0.38  (0.283) -0.20  (0.464)
Reticulocytes: Day 3 Number Analyzed 14 participants 6 participants 14 participants 5 participants
-0.00989  (0.032767) -0.00392  (0.018792) -0.01735  (0.025837) -0.01694  (0.029436)
Reticulocytes: Day 5 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.01793  (0.023690) -0.00314  (0.025877) -0.02635  (0.024815) -0.01406  (0.024957)
Reticulocytes: Day 8 Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.00158  (0.038763) -0.00546  (0.022484) -0.01032  (0.032152) 0.01020  (0.006260)
Reticulocytes: Day 28/withdrawal Number Analyzed 14 participants 7 participants 12 participants 5 participants
0.00071  (0.020099) 0.02313  (0.018277) -0.00477  (0.030198) 0.01528  (0.018000)
8.Primary Outcome
Title Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein
Hide Description Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Grams per Litre (G/L)
Albumin: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.9  (2.12) -1.7  (2.87) -2.3  (3.15) -3.0  (4.42)
Albumin: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.8  (1.90) -1.0  (2.08) -2.3  (4.37) -2.6  (1.95)
Albumin: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-1.8  (2.75) -0.3  (2.50) -1.7  (4.12) -0.4  (3.36)
Albumin: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-1.6  (2.21) 0.4  (1.62) -1.5  (2.24) 0.2  (3.49)
Total protein: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.9  (2.84) -2.3  (4.61) -2.8  (4.55) -4.4  (5.32)
Total protein: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.9  (2.20) -1.3  (3.25) -2.9  (5.54) -4.0  (4.06)
Total protein: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-1.3  (2.92) 0.4  (2.88) -1.4  (5.77) -2.2  (5.07)
Total protein: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-3.7  (3.41) -1.0  (2.94) -3.2  (4.14) -1.0  (5.24)
9.Primary Outcome
Title Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)
Hide Description Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: International Units per litre (IU/L)
ALP: Day 3 Number Analyzed 15 participants 7 participants 16 participants 7 participants
-5.0  (6.59) -5.0  (5.48) -4.5  (6.52) -7.2  (9.04)
ALP: Day 5 Number Analyzed 15 participants 7 participants 16 participants 7 participants
-5.4  (10.96) -1.9  (6.12) -4.5  (8.83) -5.8  (5.26)
ALP: Day 8 Number Analyzed 15 participants 7 participants 16 participants 7 participants
-4.4  (8.30) -0.9  (8.32) 2.9  (9.32) 0.8  (8.56)
ALP: Day 28/withdrawal Number Analyzed 15 participants 7 participants 16 participants 7 participants
-2.8  (9.06) 4.9  (7.43) -3.8  (7.94) -1.6  (9.84)
ALT: Day 3 Number Analyzed 15 participants 7 participants 16 participants 7 participants
7.9  (28.12) -0.1  (4.14) 0.1  (5.25) -8.4  (8.38)
ALT: Day 5 Number Analyzed 15 participants 7 participants 16 participants 7 participants
4.2  (15.27) 2.4  (7.18) 0.9  (10.70) -11.8  (12.50)
ALT: Day 8 Number Analyzed 15 participants 7 participants 16 participants 7 participants
2.9  (3.92) 9.1  (10.98) 2.7  (15.18) -11.0  (20.65)
ALT: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 7 participants
2.5  (5.00) 2.4  (9.69) -2.9  (11.84) -12.8  (23.64)
AST: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
6.3  (22.53) 2.9  (5.87) -0.9  (4.60) -7.2  (4.49)
AST: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.9  (4.10) 2.4  (4.76) -2.8  (8.33) -9.4  (5.94)
AST: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.8  (5.48) 3.4  (4.54) -3.3  (7.55) -10.4  (8.91)
AST: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.2  (6.75) -1.9  (4.18) -4.9  (7.62) -9.8  (11.48)
GGT: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
9.3  (28.87) 1.0  (4.08) 0.9  (3.45) -2.6  (3.13)
GGT: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
7.4  (22.36) 5.0  (6.58) 0.8  (5.14) 0.2  (5.63)
GGT: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
3.3  (11.11) 7.4  (8.12) 1.5  (7.50) 0.2  (10.50)
GGT: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-7.6  (17.60) -1.1  (5.79) -3.5  (10.62) -0.6  (15.44)
10.Primary Outcome
Title Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Hide Description Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Micromole per Liter (UMOL/L)
Direct Bilirubin: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.3  (0.88) 0.0  (1.73) -0.5  (0.74) 0.2  (0.45)
Direct Bilirubin: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.5  (0.83) -0.6  (1.13) -0.5  (0.74) 0.2  (0.45)
Direct Bilirubin: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.1  (0.73) -0.1  (1.46) -0.1  (0.83) 0.0  (1.41)
Direct Bilirubin:Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
0.1  (1.23) -0.1  (1.21) -0.1  (0.83) 0.0  (0.00)
Total Bilirubin: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.0  (2.30) -2.0  (7.46) -1.6  (2.10) -0.8  (1.79)
Total Bilirubin: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.2  (2.73) -2.7  (6.37) 0.0  (2.56) 1.0  (1.41)
Total Bilirubin: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.9  (1.99) -0.9  (6.72) 0.5  (3.09) 2.2  (3.49)
Total Bilirubin:Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
0.1  (3.45) -0.3  (6.13) 0.5  (3.11) 2.0  (2.45)
Creatinine: Day 3; Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.47  (7.891) -4.39  (6.733) -6.58  (12.081) -8.14  (11.291)
Creatinine: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-4.38  (6.330) -7.39  (7.240) -10.16  (14.060) -11.12  (9.955)
Creatinine: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-5.79  (7.262) -10.70  (10.266) -8.87  (13.815) -10.32  (5.273)
Creatinine: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-2.54  (5.166) -4.99  (12.990) -8.24  (11.771) -5.34  (5.490)
Uric acid: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-15.1  (31.18) -9.9  (42.57) -15.1  (39.17) -45.8  (36.03)
Uric acid: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-18.0  (27.46) -47.4  (39.09) -16.3  (45.05) -54.8  (33.69)
Uric acid: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
20.8  (48.26) -14.3  (53.04) 0.9  (27.41) -13.0  (69.07)
Uric acid: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
30.1  (47.40) -0.4  (48.19) 12.5  (45.09) 40.6  (63.50)
11.Primary Outcome
Title Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Hide Description Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter (MMOL/L)
Calcium: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.036  (0.0735) 0.020  (0.0370) -0.046  (0.1015) -0.092  (0.1101)
Calcium: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.029  (0.0917) 0.019  (0.0672) -0.033  (0.1079) -0.052  (0.0642)
Calcium: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.010  (0.0842) 0.053  (0.0720) 0.030  (0.0994) 0.004  (0.1178)
Calcium: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.019  (0.1077) 0.099  (0.0334) 0.031  (0.0842) 0.098  (0.1274)
CO2 / Bicarbonate: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.1  (2.74) 0.9  (2.34) 0.3  (2.50) -1.8  (2.77)
CO2 / Bicarbonate: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.4  (2.35) 0.9  (1.07) -0.5  (2.45) -1.4  (3.21)
CO2 / Bicarbonate: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.6  (3.10) -0.1  (1.95) 0.4  (2.67) -0.2  (1.10)
CO2 / Bicarbonate: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.4  (2.59) 1.1  (3.13) -0.5  (2.44) -1.2  (1.64)
Glucose: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.28  (1.084) 0.23  (1.680) 0.51  (1.385) 0.62  (0.782)
Glucose: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.13  (1.084) 0.13  (1.529) 0.29  (1.904) 1.30  (2.374)
Glucose: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.20  (1.301) -0.16  (1.042) -0.13  (1.669) 0.48  (0.733)
Glucose: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
0.27  (1.221) 0.71  (2.685) 0.43  (1.909) 0.22  (0.760)
Potassium: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.12  (0.351) 0.13  (0.411) 0.01  (0.237) -0.12  (0.396)
Potassium: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.07  (0.401) 0.16  (0.428) 0.11  (0.317) 0.08  (0.572)
Potassium: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.08  (0.353) 0.21  (0.285) 0.15  (0.223) 0.02  (0.409)
Potassium: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.04  (0.455) 0.07  (0.419) 0.14  (0.422) 0.24  (0.635)
Sodium: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.5  (1.77) 0.1  (2.41) 1.4  (1.64) 2.0  (1.87)
Sodium: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.3  (2.82) 1.1  (1.86) 0.7  (2.63) 1.8  (2.39)
Sodium: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.9  (2.64) 0.3  (1.70) 1.5  (2.33) 2.4  (1.67)
Sodium: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
-0.3  (1.82) 0.6  (2.99) 0.6  (2.50) 1.6  (1.34)
Urea/BUN: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.31  (0.956) -0.31  (0.888) 0.29  (1.046) -0.24  (1.328)
Urea/BUN: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.47  (0.830) -0.19  (1.194) 0.32  (1.197) -0.88  (1.413)
Urea/BUN: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.90  (1.563) 0.17  (1.081) 0.82  (1.050) 0.32  (1.134)
Urea/BUN: Day 28/withdrawal Number Analyzed 14 participants 7 participants 14 participants 5 participants
0.60  (1.091) 0.96  (2.082) 1.19  (0.910) 0.66  (1.324)
12.Primary Outcome
Title Change From Baseline in Urinalysis Parameters- Urine pH
Hide Description Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1), Day 5 and Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Points on a scale
Day 5 Number Analyzed 14 participants 7 participants 15 participants 5 participants
0.00  (0.784) 0.21  (0.951) 0.20  (0.592) 0.40  (0.652)
Day 28/withdrawal Number Analyzed 13 participants 7 participants 14 participants 5 participants
0.27  (0.633) 0.14  (0.852) 0.07  (0.938) 0.70  (0.570)
13.Primary Outcome
Title Change From Baseline in Urinalysis Parameters- Urine Specific Gravity
Hide Description Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary 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. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1), Day 5 and Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Ratio
Day 5 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.0001  (0.00469) -0.0004  (0.00675) -0.0038  (0.00731) -0.0076  (0.00385)
Day 28/withdrawal Number Analyzed 13 participants 7 participants 14 participants 5 participants
-0.0045  (0.00702) 0.0013  (0.00929) -0.0021  (0.00855) -0.0050  (0.00656)
14.Primary Outcome
Title Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)
Hide Description The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 4 2 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
1+
2
  50.0%
1
  50.0%
1
  25.0%
2+
1
  25.0%
1
  50.0%
1
  25.0%
3+
1
  25.0%
0
   0.0%
0
   0.0%
4+
0
   0.0%
0
   0.0%
2
  50.0%
15.Primary Outcome
Title Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)
Hide Description The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 1 1 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1+ OR 1/4 G/DL (%)
0
   0.0%
1
 100.0%
0
   0.0%
2+ OR 1/2 G/DL (%)
1
 100.0%
0
   0.0%
0
   0.0%
3+ OR 1 G/DL (%)
0
   0.0%
0
   0.0%
1
 100.0%
4+
0
   0.0%
0
   0.0%
0
   0.0%
16.Primary Outcome
Title Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)
Hide Description The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 3 1 3 1
Measure Type: Count of Participants
Unit of Measure: Participants
1+
3
 100.0%
0
   0.0%
3
 100.0%
1
 100.0%
2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3+
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
4+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
17.Primary Outcome
Title Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
DBP: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-2.1  (8.07) -0.7  (7.97) -1.1  (9.18) -4.2  (3.90)
DBP: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.3  (6.76) -1.1  (8.76) -2.1  (8.53) -5.2  (6.98)
DBP: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-4.4  (7.13) -4.6  (10.36) -2.3  (7.96) -0.8  (5.07)
DBP: Day 14 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-4.5  (7.43) -0.7  (10.63) 0.8  (9.66) -7.8  (4.87)
DBP: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 6 participants
-4.4  (10.37) -0.6  (13.82) -1.1  (8.18) -3.5  (6.57)
SBP: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-5.73  (13.599) -5.29  (8.597) -2.87  (6.802) -5.00  (5.568)
SBP: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-3.00  (11.802) -0.71  (4.923) -1.93  (11.279) -3.00  (8.456)
SBP: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-5.86  (19.907) -9.29  (13.889) -2.60  (13.741) 0.60  (10.164)
SBP: Day 14 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-6.20  (12.260) -4.57  (10.163) -1.20  (12.667) -3.80  (7.259)
SBP: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 6 participants
-3.36  (16.284) -0.43  (7.115) -0.80  (6.982) -2.83  (7.278)
18.Primary Outcome
Title Change From Baseline in Vital Signs- Heart Rate (HR)
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Heart rate: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
3.93  (10.375) -8.00  (14.855) -8.87  (11.637) -1.20  (16.976)
Heart rate: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-2.60  (7.385) -10.29  (21.109) -9.60  (14.161) -6.80  (12.637)
Heart rate: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-2.79  (10.297) -12.29  (21.422) -10.87  (14.589) -0.80  (17.541)
Heart rate: Day 14 Number Analyzed 15 participants 7 participants 15 participants 5 participants
0.80  (13.165) -13.43  (14.444) -8.73  (14.553) -4.20  (17.584)
Heart rate: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 6 participants
-6.57  (11.043) -17.14  (19.912) -11.80  (15.799) 0.17  (12.952)
19.Primary Outcome
Title Change From Baseline in Vital Signs- Respiration Rate (RR)
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
RR: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.1  (2.03) 0.0  (2.00) -0.5  (2.23) 1.4  (1.95)
RR: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.5  (2.10) 0.0  (1.63) -0.7  (2.58) 1.2  (1.10)
RR: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.3  (2.46) 0.7  (2.21) -0.6  (2.38) 0.6  (1.34)
RR: Day 14 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.7  (2.66) 0.6  (2.23) -0.3  (2.77) 0.8  (1.10)
RR: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 6 participants
-0.4  (2.02) 0.4  (3.46) -0.3  (2.97) 0.8  (2.23)
20.Primary Outcome
Title Change From Baseline in Vital Signs- Temperature
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Centigrade
Temperature: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.20  (1.342) -1.11  (0.749) -0.57  (0.884) -0.08  (0.239)
Temperature: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.75  (1.278) -1.34  (0.978) -0.76  (0.766) -0.14  (0.422)
Temperature: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.46  (0.818) -1.50  (1.127) -0.83  (0.786) -0.16  (0.537)
Temperature: Day 14 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.73  (1.177) -1.59  (1.051) -0.83  (0.970) -0.28  (0.409)
Temperature: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 6 participants
-0.71  (1.240) -1.39  (0.958) -0.71  (0.905) -0.22  (0.454)
21.Primary Outcome
Title Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)
Hide Description Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Percentage (%)
POB: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-1.7  (3.97) 1.1  (1.68) 0.1  (1.60) 0.4  (2.61)
POB: Day 5 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.7  (1.35) -0.4  (3.10) 0.4  (1.76) 1.0  (2.00)
POB: Day 8 Number Analyzed 14 participants 7 participants 15 participants 5 participants
-0.8  (1.31) 0.4  (1.62) -0.1  (2.09) 0.8  (3.70)
POB: Day 14 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-0.7  (1.71) 0.9  (3.13) 0.0  (1.77) 0.8  (2.39)
POB: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 6 participants
-1.1  (1.83) 1.1  (1.86) 0.2  (1.42) 1.5  (2.88)
22.Primary Outcome
Title Change From Baseline in Electrocardiogram (ECG) Parameters
Hide Description 12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette’s formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Mean (Standard Deviation)
Unit of Measure: Millisecond (msec)
RR Interval: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
-5.8  (123.37) 49.4  (75.29) 83.0  (144.39) 39.2  (200.77)
RR Interval: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 5 participants
58.2  (94.94) 76.9  (151.52) 107.4  (195.56) 41.2  (103.82)
QT Interval: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
3.1  (25.90) 25.0  (19.86) 17.7  (28.78) 30.7  (38.72)
QT Interval: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 5 participants
18.9  (19.35) 35.9  (20.36) 25.3  (39.96) 11.1  (16.79)
QTcF: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
4.5  (21.76) 18.8  (13.90) 6.5  (12.89) 24.6  (13.03)
QTcF:Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 5 participants
11.0  (14.10) 24.8  (11.73) 11.0  (18.07) 4.3  (5.31)
QTcB: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
4.1  (25.69) 14.3  (11.93) 0.3  (12.63) 20.9  (8.83)
QTcB: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 5 participants
6.6  (15.25) 17.0  (22.12) 3.5  (14.03) 0.1  (7.16)
PR Interval: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
2.4  (6.47) -5.4  (20.25) 0.4  (10.53) 2.3  (10.52)
PR Interval: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 5 participants
3.1  (6.33) 9.3  (11.87) 3.0  (13.47) 2.5  (5.27)
QRS Duration: Day 3 Number Analyzed 15 participants 7 participants 15 participants 5 participants
1.5  (4.45) -5.6  (6.47) -0.5  (6.14) 1.9  (8.92)
QRS Duration: Day 28/withdrawal Number Analyzed 14 participants 7 participants 15 participants 5 participants
-1.3  (5.29) -5.7  (12.47) 0.6  (8.77) 0.3  (4.09)
23.Primary Outcome
Title Number of Participants With Disease Related Events (DREs) of Interest
Hide Description Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  13.3%
0
   0.0%
1
   6.3%
0
   0.0%
24.Primary Outcome
Title Number of Participants With DRE of Interest-associated Antibiotic Use
Hide Description Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
25.Secondary Outcome
Title Time to Resolution of Fever Over Time Post Initiation of Treatment
Hide Description Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Influenza positive population (IPP) comprised of all randomized participants who received at least one dose of IP with proven influenza infection (positive rapid antigen test and positive influenza by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) or culture test at any time point). Participants with fever are analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 7 6 12 5
Median (Full Range)
Unit of Measure: Hours
119.833 [1] 
(15.167 to NA)
98.092
(46.033 to 129.917)
54.425 [1] 
(13.833 to NA)
76.167 [1] 
(18.150 to NA)
[1]
Missing Kaplan Meier estimates are due to censoring
26.Secondary Outcome
Title Number of Afebrile Participants Over Time Post Initiation of Treatment
Hide Description Afebrile participants were defined as participants with oral temperature <=37.2 degree Celsius, <=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
IPP population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 7 6 12 5
Measure Type: Count of Participants
Unit of Measure: Participants
At 0 hour
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
At 24 hours
1
  14.3%
0
   0.0%
2
  16.7%
1
  20.0%
At 72 hours
2
  28.6%
2
  33.3%
8
  66.7%
2
  40.0%
At 120 hours
4
  57.1%
4
  66.7%
10
  83.3%
3
  60.0%
At 192 hours
4
  57.1%
6
 100.0%
11
  91.7%
3
  60.0%
At 336 hours
5
  71.4%
6
 100.0%
11
  91.7%
3
  60.0%
At 672 hours
5
  71.4%
6
 100.0%
11
  91.7%
3
  60.0%
27.Secondary Outcome
Title Number of Participants Who Used Relief Medication
Hide Description Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Measure Type: Count of Participants
Unit of Measure: Participants
Paracetamol use
12
  80.0%
7
 100.0%
15
  93.8%
7
 100.0%
Dextromethorphan use
12
  80.0%
5
  71.4%
13
  81.3%
7
 100.0%
28.Secondary Outcome
Title Number of Hospital Admissions Due to Influenza Infection
Hide Description Number of participants admitted in hospital due to influenza infection was recorded.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
29.Secondary Outcome
Title Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Hide Description Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
IPP population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 9 6 13 7
Mean (Standard Deviation)
Unit of Measure: Log viral particles/mL
Day 3 Number Analyzed 9 participants 6 participants 12 participants 5 participants
-0.897  (1.1390) -1.415  (1.5986) -1.620  (1.3461) -1.904  (1.6289)
Day 5 Number Analyzed 9 participants 6 participants 12 participants 5 participants
-1.912  (1.2895) -2.812  (1.8841) -2.962  (1.8515) -2.644  (0.5206)
Day 8 Number Analyzed 8 participants 6 participants 12 participants 5 participants
-3.764  (1.8831) -4.063  (1.4120) -3.862  (1.3284) -4.250  (1.7995)
Day 14 Number Analyzed 9 participants 5 participants 12 participants 5 participants
-4.024  (1.0387) -4.992  (1.1296) -4.518  (1.2408) -4.250  (1.7995)
30.Secondary Outcome
Title Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Hide Description Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
Time Frame Up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
IPP Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 mg Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 milligram (mg) oral danirixin twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral danirixin twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Participants received danirixin matching placebo twice daily with 75 mg oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 9 6 13 7
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 9 participants 6 participants 13 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 3 Number Analyzed 9 participants 6 participants 12 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 5 Number Analyzed 9 participants 6 participants 12 participants 5 participants
0
   0.0%
0
   0.0%
3
  25.0%
1
  20.0%
Day 8 Number Analyzed 8 participants 6 participants 12 participants 5 participants
3
  37.5%
1
  16.7%
6
  50.0%
5
 100.0%
Day 14 Number Analyzed 9 participants 5 participants 12 participants 5 participants
5
  55.6%
4
  80.0%
11
  91.7%
5
 100.0%
31.Secondary Outcome
Title Total Dose of Relief Medication
Hide Description Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.
Time Frame Up to Day 28/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants using relief medication were analyzed.
Arm/Group Title Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 15 7 16 7
Median (Full Range)
Unit of Measure: Milligrams
Paracetamol total dose Number Analyzed 12 participants 7 participants 15 participants 7 participants
5000.00
(1000.0 to 14000.0)
9000.00
(500.0 to 71000.0)
5500.00
(500.0 to 20000.0)
3000.00
(1000.0 to 12000.0)
Dextromethorphan total dose Number Analyzed 12 participants 5 participants 13 participants 7 participants
150.00
(15.0 to 360.0)
390.00
(120.0 to 2250.0)
120.00
(30.0 to 2250.0)
60.00
(15.0 to 300.0)
32.Secondary Outcome
Title Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Hide Description Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Time Frame Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
IPP population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 9 6 13 7
Mean (Standard Deviation)
Unit of Measure: Log median tissue culture infective dose
Day 3 Number Analyzed 9 participants 6 participants 12 participants 5 participants
-1.810  (1.4374) -0.753  (1.8251) -1.943  (2.0079) -2.304  (1.9351)
Day 5 Number Analyzed 9 participants 6 participants 12 participants 5 participants
-2.534  (1.4499) -2.172  (1.9242) -2.467  (1.8842) -3.108  (2.0998)
Day 8 Number Analyzed 8 participants 6 participants 12 participants 5 participants
-2.885  (1.1877) -2.843  (2.2061) -2.698  (1.4621) -3.108  (2.0998)
Day 14 Number Analyzed 9 participants 5 participants 12 participants 5 participants
-2.564  (1.4694) -2.260  (1.8792) -2.614  (1.5899) -3.108  (2.0998)
33.Secondary Outcome
Title Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Hide Description Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
Time Frame Up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
IPP Population. Only those participants (number with nasopharyngeal samples) available at the specified time points were analyzed.
Arm/Group Title Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description:
Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Overall Number of Participants Analyzed 9 6 13 7
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1 Number Analyzed 9 participants 6 participants 13 participants 7 participants
1
  11.1%
0
   0.0%
0
   0.0%
2
  28.6%
Day 3 Number Analyzed 9 participants 6 participants 12 participants 5 participants
5
  55.6%
2
  33.3%
6
  50.0%
3
  60.0%
Day 5 Number Analyzed 9 participants 6 participants 12 participants 5 participants
7
  77.8%
3
  50.0%
10
  83.3%
5
 100.0%
Day 8 Number Analyzed 8 participants 6 participants 12 participants 5 participants
8
 100.0%
6
 100.0%
12
 100.0%
5
 100.0%
Day 14 Number Analyzed 9 participants 5 participants 12 participants 5 participants
9
 100.0%
5
 100.0%
12
 100.0%
5
 100.0%
Time Frame Up to 28 days
Adverse Event Reporting Description Safety population comprised of all randomized participants who received at least one dose of investigational product.
 
Arm/Group Title Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Hide Arm/Group Description Participants received 75 mg oral Danirixin twice daily with Oseltamivir matching placebo (PBO [OSV]) twice daily for a total of ten doses over five days Participants received Danirixin matching placebo (PBO [DNX]) twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days Participants received 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days Participants received Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
All-Cause Mortality
Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/7 (0.00%)   0/16 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)   0/7 (0.00%)   0/16 (0.00%)   0/7 (0.00%) 
Investigations         
Electrocardiogram T wave abnormal  1  1/15 (6.67%)  0/7 (0.00%)  0/16 (0.00%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Danirixin (DNX) 75 Milligram (mg) Placebo (PBO) Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg Oseltamivir (OSV) 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)   2/7 (28.57%)   3/16 (18.75%)   0/7 (0.00%) 
Gastrointestinal disorders         
Diarrhoea  1  1/15 (6.67%)  1/7 (14.29%)  0/16 (0.00%)  0/7 (0.00%) 
Vomiting  1  0/15 (0.00%)  0/7 (0.00%)  2/16 (12.50%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  0/15 (0.00%)  1/7 (14.29%)  1/16 (6.25%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02469298     History of Changes
Other Study ID Numbers: 201682
First Submitted: April 23, 2015
First Posted: June 11, 2015
Results First Submitted: July 23, 2017
Results First Posted: August 24, 2017
Last Update Posted: July 23, 2019