Trial Outcomes & Findings for Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms (NCT NCT03629184)
NCT ID: NCT03629184
Last Updated: 2020-04-29
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Up to Day 29
Results posted on
2020-04-29
Participant Flow
Participant milestones
| Measure |
Baloxavir Marboxil
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
58
|
|
Overall Study
COMPLETED
|
112
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Baloxavir Marboxil
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
Baseline characteristics by cohort
| Measure |
Baloxavir Marboxil
n=115 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=58 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.10 years
STANDARD_DEVIATION 2.90 • n=5 Participants
|
6.02 years
STANDARD_DEVIATION 3.20 • n=7 Participants
|
6.08 years
STANDARD_DEVIATION 3.00 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
98 participants
n=5 Participants
|
51 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
52 participants
n=5 Participants
|
27 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
63 participants
n=5 Participants
|
31 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Outcome measures
| Measure |
Baloxavir Marboxil
n=115 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=58 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs)
|
46.1 percentage of participants
|
53.4 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 (Post-Dose), 2, 4, 6 and 10Population: The pharmacokinetic (PK) population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Sparse PK population comprises all participants in the PK population who did not provide informed consent to intensive PK sampling
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Outcome measures
| Measure |
Baloxavir Marboxil
n=88 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
5 - <10 kg (Day 1)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
5 - <10 kg (Day 2)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
5 - <10 kg (Day 6)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
10 - <15 kg (Day 1)
|
0.073 ng/mL
Standard Deviation 0.2001
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
10 - <15 kg (Day 2)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
10 - <15 kg (Day 4)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
10 - <15 kg (Day 6)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
10 - <15 kg (Day 10)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
15 - <20 kg (Day 1)
|
0.090 ng/mL
Standard Deviation 0.2386
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
15 - <20 kg (Day 2)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
15 - <20 kg (Day 4)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
15 - <20 kg (Day 6)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
15 - <20 kg (Day 10)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
>=20 kg (Day 1)
|
0.048 ng/mL
Standard Deviation 0.1936
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
>=20 kg (Day 2)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
>=20 kg (Day 4)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
>=20 kg (Day 6)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population
>=20 kg (Day 10)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Post-Dose), 2, 4, 6 and 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Sparse PK population comprises all participants in the PK population who did not provide informed consent to intensive PK sampling
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm.
Outcome measures
| Measure |
Baloxavir Marboxil
n=88 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Plasma Concentrations of S-033447 - Sparse PK Population
5 - <10 kg (Day 1)
|
45.700 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
5 - <10 kg (Day 2)
|
45.800 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
5 - <10 kg (Day 6)
|
3.110 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
10 - <15 kg (Day 1)
|
49.084 ng/mL
Standard Deviation 53.6689
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
10 - <15 kg (Day 2)
|
42.900 ng/mL
Standard Deviation 16.5227
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
10 - <15 kg (Day 4)
|
9.233 ng/mL
Standard Deviation 5.3879
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
10 - <15 kg (Day 6)
|
2.965 ng/mL
Standard Deviation 1.6480
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
10 - <15 kg (Day 10)
|
0.367 ng/mL
Standard Deviation 0.6351
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
15 - <20 kg (Day 1)
|
64.160 ng/mL
Standard Deviation 73.6320
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
15 - <20 kg (Day 2)
|
67.729 ng/mL
Standard Deviation 46.7346
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
15 - <20 kg (Day 4)
|
15.840 ng/mL
Standard Deviation 10.8285
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
15 - <20 kg (Day 6)
|
4.829 ng/mL
Standard Deviation 3.6562
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
15 - <20 kg (Day 10)
|
1.110 ng/mL
Standard Deviation 1.9226
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
>=20 kg (Day 1)
|
29.899 ng/mL
Standard Deviation 26.1558
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
>=20 kg (Day 2)
|
56.287 ng/mL
Standard Deviation 40.4073
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
>=20 kg (Day 4)
|
18.674 ng/mL
Standard Deviation 11.2179
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
>=20 kg (Day 6)
|
7.397 ng/mL
Standard Deviation 5.0530
|
—
|
|
Plasma Concentrations of S-033447 - Sparse PK Population
>=20 kg (Day 10)
|
3.953 ng/mL
Standard Deviation 2.2536
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Post-Dose), 2, 4, 6 and 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Extensive PK population comprises all participants in the PK population who provided informed consent to intensive PK sampling (additional time points for sample collection on Day 1)
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Outcome measures
| Measure |
Baloxavir Marboxil
n=19 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 0.5 - 2 hrs (10 - <15 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 4 hrs (10 - <15 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 6 hrs (10 - <15 kg)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 2 (10 - <15 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 4 (10 - <15 kg)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 6 (10 - <15 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 10 (10 - <15 kg )
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 0.5 - 2 hrs (15 - <20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 4 hrs (15 - <20 kg)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 6 hrs (15 - <20 kg)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 2 (15 - <20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 4 (15 - <20 kg)
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 6 (15 - <20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 0.5 - 2 hrs (>=20 kg)
|
0.051 ng/mL
Standard Deviation 0.1600
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 4 hrs (>=20 kg)
|
0.062 ng/mL
Standard Deviation 0.1863
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 1, 6 hrs ((>=20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 2 (>=20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 4 (>=20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population
Day 6 (>=20 kg)
|
0.000 ng/mL
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Days 1 (Post-Dose), 2, 4, 6 and 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Extensive PK population comprises all participants in the PK population who provided informed consent to intensive PK sampling (additional time points for sample collection on Day 1)
Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.
Outcome measures
| Measure |
Baloxavir Marboxil
n=19 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 0.5 - 2 hrs (10 - <15 kg)
|
10.768 ng/mL
Standard Deviation 14.7987
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 4 hrs (10 - <15 kg)
|
49.500 ng/mL
Standard Deviation 13.0108
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 6 hrs (10 - <15 kg)
|
41.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 2 (10 - <15 kg)
|
28.933 ng/mL
Standard Deviation 14.7514
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 4 (10 - <15 kg)
|
2.230 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 6 (10 - <15 kg)
|
3.131 ng/mL
Standard Deviation 2.2828
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 10 (10 - <15 kg )
|
0.000 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 0.5 - 2 hrs (15 - <20 kg)
|
93.883 ng/mL
Standard Deviation 152.5431
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 4 hrs (15 - <20 kg)
|
72.900 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 6 hrs (15 - <20 kg)
|
80.300 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 2 (15 - <20 kg)
|
42.640 ng/mL
Standard Deviation 47.6024
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 4 (15 - <20 kg)
|
12.200 ng/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 6 (15 - <20 kg)
|
2.663 ng/mL
Standard Deviation 1.5387
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 0.5 - 2 hrs (>=20 kg)
|
19.923 ng/mL
Standard Deviation 27.0980
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 4 hrs (>=20 kg)
|
69.198 ng/mL
Standard Deviation 55.7220
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 1, 6 hrs ((>=20 kg)
|
65.527 ng/mL
Standard Deviation 43.0799
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 2 (>=20 kg)
|
57.980 ng/mL
Standard Deviation 37.8922
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 4 (>=20 kg)
|
21.775 ng/mL
Standard Deviation 3.7968
|
—
|
|
Plasma Concentrations of S-033447 - Extensive PK Population
Day 6 (>=20 kg)
|
6.240 ng/mL
Standard Deviation 3.3702
|
—
|
SECONDARY outcome
Timeframe: Up to Day 15Population: Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study
Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met and remain so for at least 21.5 hours: * A score of 0 (no problem) or 1 (minor problem) for cough and nasal symptoms (items 14 and 15 of the Canadian Acute Respiratory Illness and Flu Scale \[CARIFS\]) * A "yes" response to the following question on the CARIFS: "Since the last assessment has the subject been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?" * First return to afebrile state (tympanic temperature ≤37.2 degree Celsius \[°C\])
Outcome measures
| Measure |
Baloxavir Marboxil
n=80 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Time to Alleviation of Influenza Signs and Symptoms
|
138.1 hours
Interval 116.6 to 163.2
|
150.0 hours
Interval 115.0 to 165.7
|
SECONDARY outcome
Timeframe: Up to Day 15Population: Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study.
Length of time taken by participants to return to afebrile state \[tympanic temperature ≤ 37.2°C\] and remaining so for at least 21.5 hours.
Outcome measures
| Measure |
Baloxavir Marboxil
n=80 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Duration of Fever
|
41.2 hours
Interval 24.5 to 45.7
|
46.8 hours
Interval 30.0 to 53.5
|
SECONDARY outcome
Timeframe: Up to Day 15Population: Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study.
The clinical efficacy of baloxavir marboxil is evaluated by duration of symptoms i.e., alleviation of all symptoms as defined by a score of 0 \[no problem\] or 1 \[minor problem\] and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire.
Outcome measures
| Measure |
Baloxavir Marboxil
n=80 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Duration of Symptoms
|
66.4 hours
Interval 43.7 to 76.4
|
67.9 hours
Interval 45.8 to 88.7
|
SECONDARY outcome
Timeframe: Up to Day 15Population: Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study.
Time to Return to Normal health and activity' is identified by a 'Yes' response to the following question on the CARIFS: "Since the last assessment has the patient been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?"
Outcome measures
| Measure |
Baloxavir Marboxil
n=80 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Time to Return to Normal Health and Activity
|
116.5 hours
Interval 94.9 to 138.0
|
111.6 hours
Interval 80.8 to 138.3
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Includes all participants who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Outcome measures
| Measure |
Baloxavir Marboxil
n=81 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Frequency of Influenza-Related Complications
Total
|
6 count of events
|
4 count of events
|
|
Frequency of Influenza-Related Complications
Death
|
0 count of events
|
0 count of events
|
|
Frequency of Influenza-Related Complications
Hospitalization
|
0 count of events
|
0 count of events
|
|
Frequency of Influenza-Related Complications
Sinusitis
|
1 count of events
|
0 count of events
|
|
Frequency of Influenza-Related Complications
Otitis Media
|
3 count of events
|
3 count of events
|
|
Frequency of Influenza-Related Complications
Pneumonia
|
1 count of events
|
0 count of events
|
|
Frequency of Influenza-Related Complications
Bronchitis
|
1 count of events
|
0 count of events
|
|
Frequency of Influenza-Related Complications
Encephalitis/Encephalopathy
|
0 count of events
|
0 count of events
|
|
Frequency of Influenza-Related Complications
Febrile Seizures
|
0 count of events
|
1 count of events
|
|
Frequency of Influenza-Related Complications
Myositis
|
0 count of events
|
0 count of events
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Includes all participants who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study
Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Outcome measures
| Measure |
Baloxavir Marboxil
n=81 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Percentage of Participants With Influenza-Related Complications
Total
|
7.4 percentage of participants
|
7.0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Death
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Hospitalization
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Sinusitis
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Otitis Media
|
3.7 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Pneumonia
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Bronchitis
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Encephalitis/Encephalopathy
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Febrile Seizures
|
0 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants With Influenza-Related Complications
Myositis
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Includes all participants who have had a laboratory confirmation of influenza infection (polymerase chain reaction \[PCR\] result) from any swab sample collected at baseline or during the study
Outcome measures
| Measure |
Baloxavir Marboxil
n=81 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=43 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Percentage of Participants Requiring Antibiotics
Total
|
4.9 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants Requiring Antibiotics
Bronchitis
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Requiring Antibiotics
Otitis Media
|
2.5 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants Requiring Antibiotics
Pneumonia
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Requiring Antibiotics
Sinusitis
|
1.2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 29Population: Includes all participants with post-baseline Virology assessment and a positive virus titer on Day 1
Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of any study treatment and first time when the influenza virus titer is below the limit of detection.
Outcome measures
| Measure |
Baloxavir Marboxil
n=67 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=37 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Time to Cessation of Viral Shedding by Virus Titer
|
24.2 hours
Interval 23.5 to 24.6
|
75.8 hours
Interval 68.9 to 97.8
|
SECONDARY outcome
Timeframe: Day 1 - Day 29Population: Includes all participants with post-baseline Virology assessment and a positive virus RNA by RT-PCR on Day 1. Participants whose virus RNA did not reach the limit by the last observation time point are treated as censored at that time point.
Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of any study treatment and first time when the virus RNA by RT-PCR is below the limit of detection.
Outcome measures
| Measure |
Baloxavir Marboxil
n=76 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=39 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Time to Cessation of Viral Shedding by RT-PCR
|
242.5 hours
Interval 235.8 to 262.8
|
238.9 hours
Interval 214.0 to 286.7
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29Population: Includes all participants with a positive virus titer on Day 1
Influenza virus titer (log10TCID50/ML) is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10TCID50/mL). A lower value indicates lower viral titer.
Outcome measures
| Measure |
Baloxavir Marboxil
n=67 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=38 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Baseline
|
4.43 log10TCID50/ML
Standard Deviation 1.36
|
4.27 log10TCID50/ML
Standard Deviation 1.48
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 2
|
-3.59 log10TCID50/ML
Standard Deviation 1.34
|
-1.79 log10TCID50/ML
Standard Deviation 1.54
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 3 (optional visit)
|
-2.83 log10TCID50/ML
Standard Deviation 0.58
|
-2.63 log10TCID50/ML
Standard Deviation 0.88
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 4
|
-3.53 log10TCID50/ML
Standard Deviation 1.38
|
-3.27 log10TCID50/ML
Standard Deviation 1.54
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 6
|
-3.55 log10TCID50/ML
Standard Deviation 1.32
|
-3.52 log10TCID50/ML
Standard Deviation 1.50
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 10
|
-3.66 log10TCID50/ML
Standard Deviation 1.40
|
-3.50 log10TCID50/ML
Standard Deviation 1.42
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 15 (optional visit)
|
-3.75 log10TCID50/ML
Standard Deviation 0.54
|
-3.63 log10TCID50/ML
Standard Deviation 1.45
|
|
Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29
Day 29
|
-3.50 log10TCID50/ML
Standard Deviation 1.43
|
-3.75 log10TCID50/ML
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29Population: Includes all participants with positive virus RNA by RT-PCR on Day 1
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Outcome measures
| Measure |
Baloxavir Marboxil
n=76 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=40 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Baseline
|
6.46 log10 virus particles/mL
Standard Deviation 1.50
|
6.86 log10 virus particles/mL
Standard Deviation 1.02
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 2
|
-1.74 log10 virus particles/mL
Standard Deviation 1.13
|
-1.12 log10 virus particles/mL
Standard Deviation 1.12
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 3 (optional)
|
-1.78 log10 virus particles/mL
Standard Deviation 1.50
|
-2.21 log10 virus particles/mL
Standard Deviation 0.94
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 4
|
-2.40 log10 virus particles/mL
Standard Deviation 1.50
|
-2.47 log10 virus particles/mL
Standard Deviation 1.35
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 6
|
-2.73 log10 virus particles/mL
Standard Deviation 1.78
|
-3.32 log10 virus particles/mL
Standard Deviation 1.27
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 10
|
-3.55 log10 virus particles/mL
Standard Deviation 1.62
|
-3.81 log10 virus particles/mL
Standard Deviation 1.19
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 15 (optional)
|
-1.24 log10 virus particles/mL
Standard Deviation 3.06
|
-4.44 log10 virus particles/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation.
|
|
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29
Day 29
|
2.18 log10 virus particles/mL
Standard Deviation NA
Insufficient number of participants available to calculate the standard deviation.
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 2, 3 (optional), 4, 6, 10Population: Includes all participants with a positive virus titer on Day 1
Outcome measures
| Measure |
Baloxavir Marboxil
n=67 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=38 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Baseline
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Day 2
|
15.6 percentage of participants
|
75.7 percentage of participants
|
|
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Day 3 (optional)
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Day 4
|
26.2 percentage of participants
|
29.0 percentage of participants
|
|
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Day 6
|
12.7 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10
Day 10
|
1.6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29Population: Includes all participants with positive virus RNA by RT-PCR on Day 1
Outcome measures
| Measure |
Baloxavir Marboxil
n=76 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=40 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Baseline
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 2
|
95.9 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 3 (optional)
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 4
|
89.9 percentage of participants
|
97.0 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 6
|
83.1 percentage of participants
|
75.7 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 10
|
46.5 percentage of participants
|
44.1 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 15 (optional)
|
40.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29
Day 29
|
25.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 29Population: Includes all participants with post-baseline Virology assessment and a positive virus titer on Day 1
Area under the curve (AUC) in virus titer was calculated using the trapezoidal method.
Outcome measures
| Measure |
Baloxavir Marboxil
n=67 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=37 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Area Under the Curve in Virus Titer
|
-863.81 log₁₀[TCID₅₀/mL]*hours
Standard Deviation 543.37
|
-849.29 log₁₀[TCID₅₀/mL]*hours
Standard Deviation 684.43
|
SECONDARY outcome
Timeframe: Day 1 - Day 10Population: Includes all participants with positive virus RNA by RT-PCR on Day 1 and at least 1 post-baseline test.
AUC in virus RNA (RT-PCR) is defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 10. AUC is calculated using the trapezoidal method similar to AUC in virus titer.
Outcome measures
| Measure |
Baloxavir Marboxil
n=75 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=39 Participants
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Area Under the Curve in the Amount of Virus RNA (RT-PCR)
|
-381.53 log₁₀ VPs/mL*hours
Standard Deviation 338.53
|
-353.31 log₁₀ VPs/mL*hours
Standard Deviation 304.01
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil
Non-Asian - 2 mg/kg
|
NA ng.hr/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil
Asian - 40 mg
|
NA ng.hr/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil
Non-Asian - 40 mg
|
NA ng.hr/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.
Non-Asian - 2 mg/kg
|
4050 ng.hr/mL
Standard Deviation 2080
|
—
|
|
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.
Asian - 40 mg
|
6600 ng.hr/mL
Standard Deviation NA
Not estimable due to low number of events
|
—
|
|
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.
Non-Asian - 40 mg
|
4390 ng.hr/mL
Standard Deviation 2080
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil
Non-Asian - 2 mg/kg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil
Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil
Non-Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of S-033447
Non-Asian - 2 mg/kg
|
109 ng/mL
Standard Deviation 55.3
|
—
|
|
Maximum Plasma Concentration (Cmax) of S-033447
Asian - 40 mg
|
110 ng/mL
Standard Deviation NA
Not estimable due to low number of events.
|
—
|
|
Maximum Plasma Concentration (Cmax) of S-033447
Non-Asian - 40 mg
|
83.2 ng/mL
Standard Deviation 36.5
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil
Non-Asian - 2 mg/kg
|
NA hours
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil
Asian - 40 mg
|
NA hours
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil
Non-Asian - 40 mg
|
NA hours
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
SECONDARY outcome
Timeframe: Up to Day 10Population: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of S-033447
Non-Asian - 2 mg/kg
|
4.12 hours
Standard Deviation 2.07
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of S-033447
Asian - 40 mg
|
5.50 hours
Standard Deviation NA
Not estimable due to low number of events
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of S-033447
Non-Asian - 40 mg
|
5.55 hours
Standard Deviation 3.79
|
—
|
SECONDARY outcome
Timeframe: 24, 72, 96 and 240 hours post-dosePopulation: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
24 - Non-Asian - 2 mg/kg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
24 - Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
24 - Non-Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
72 - Non-Asian - 2 mg/kg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
72 - Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
72 - Non-Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
96 - Non-Asian - 2 mg/kg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
96 - Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
96 - Non-Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
240 - Non-Asian - 2 mg/kg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
240 - Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
|
Plasma Concentrations of Baloxavir Marboxil by Dosage
240 - Non-Asian - 40 mg
|
NA ng/mL
Standard Deviation NA
Not estimable as Baloxavir marboxil is a prodrug which is rapidly metabolised into baloxavir. The concentrations are not measurable and do not allow to derive any PK parameters.
|
—
|
SECONDARY outcome
Timeframe: 24, 72, 96 and 240 hours post-dosePopulation: The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point
Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects \<20 kgs and 40 mg dose was used for subjects \>20 kgs.
Outcome measures
| Measure |
Baloxavir Marboxil
n=95 Participants
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Plasma Concentrations of S-033447 by Dosage
24 - Asian - 40 mg
|
75.2 ng/mL
Standard Deviation NA
Not estimable due to low number of events
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
24 - Non-Asian - 40 mg
|
53.2 ng/mL
Standard Deviation 22.4
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
72 - Non-Asian - 2 mg/kg
|
13.2 ng/mL
Standard Deviation 7.15
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
72 - Asian - 40 mg
|
28.9 ng/mL
Standard Deviation NA
Not estimable due to low number of events
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
72 - Non-Asian - 40 mg
|
17.90 ng/mL
Standard Deviation 8.910
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
96 - Non-Asian - 2 mg/kg
|
7.61 ng/mL
Standard Deviation 4.400
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
96 - Asian - 40 mg
|
19.0 ng/mL
Standard Deviation NA
Not estimable due to low number of events
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
96 - Non-Asian - 40 mg
|
11.3 ng/mL
Standard Deviation 6.160
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
240 - Non-Asian - 2 mg/kg
|
0.989 ng/mL
Standard Deviation 0.887
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
240 - Asian - 40 mg
|
3.31 ng/mL
Standard Deviation NA
Not estimable due to low number of events
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
240 - Non-Asian - 40 mg
|
1.85 ng/mL
Standard Deviation 1.400
|
—
|
|
Plasma Concentrations of S-033447 by Dosage
24 - Non-Asian - 2 mg/kg
|
55.7 ng/mL
Standard Deviation 28.1
|
—
|
Adverse Events
Baloxavir Marboxil
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Oseltamivir
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baloxavir Marboxil
n=115 participants at risk
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
|
Oseltamivir
n=58 participants at risk
Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
6/115 • Number of events 6 • From baseline (Day 1) until 28 days after the last dose of study drug (29 days)
|
1.7%
1/58 • Number of events 1 • From baseline (Day 1) until 28 days after the last dose of study drug (29 days)
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
7/115 • Number of events 7 • From baseline (Day 1) until 28 days after the last dose of study drug (29 days)
|
15.5%
9/58 • Number of events 10 • From baseline (Day 1) until 28 days after the last dose of study drug (29 days)
|
|
Infections and infestations
Otitis Media
|
2.6%
3/115 • Number of events 3 • From baseline (Day 1) until 28 days after the last dose of study drug (29 days)
|
6.9%
4/58 • Number of events 5 • From baseline (Day 1) until 28 days after the last dose of study drug (29 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER