Trial Outcomes & Findings for A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults (NCT NCT01078376)
NCT ID: NCT01078376
Last Updated: 2014-07-25
Results Overview
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Day 1
Results posted on
2014-07-25
Participant Flow
Participants took part in the study at 6 sites in the United States and 3 sites in the United Kingdom from 10 May 2010 to 10 July 2013.
Children between the ages of 1 to 16 years (including up to their 17th birthday) with hypertension and gender-matched healthy adults aged 18 to 45 years, inclusive, were enrolled in 1 of 3 cohorts.
Participant milestones
| Measure |
Cohort 1: Healthy Adults
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg
Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to \< 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
|
Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg
Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to \< 40 kg received a 20 mg dose, participants 40 to \< 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
8
|
3
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg
n=9 Participants
Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to \< 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
|
Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg
n=8 Participants
Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to \< 40 kg received a 20 mg dose, participants 40 to \< 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
14.2 years
STANDARD_DEVIATION 1.64 • n=7 Participants
|
9.1 years
STANDARD_DEVIATION 2.10 • n=5 Participants
|
4.7 years
STANDARD_DEVIATION 0.58 • n=4 Participants
|
16.2 years
STANDARD_DEVIATION 9.81 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Height
|
172.6 cm
STANDARD_DEVIATION 9.70 • n=5 Participants
|
163.1 cm
STANDARD_DEVIATION 11.72 • n=7 Participants
|
138.6 cm
STANDARD_DEVIATION 12.74 • n=5 Participants
|
107.7 cm
STANDARD_DEVIATION 11.06 • n=4 Participants
|
153.6 cm
STANDARD_DEVIATION 23.45 • n=21 Participants
|
|
Weight
|
74.64 kg
STANDARD_DEVIATION 11.207 • n=5 Participants
|
71.71 kg
STANDARD_DEVIATION 15.512 • n=7 Participants
|
48.50 kg
STANDARD_DEVIATION 22.523 • n=5 Participants
|
18.30 kg
STANDARD_DEVIATION 4.026 • n=4 Participants
|
60.69 kg
STANDARD_DEVIATION 23.859 • n=21 Participants
|
|
Body Mass Index (BMI)
|
25.06 kg/m^2
STANDARD_DEVIATION 3.345 • n=5 Participants
|
27.22 kg/m^2
STANDARD_DEVIATION 6.611 • n=7 Participants
|
24.29 kg/m^2
STANDARD_DEVIATION 8.327 • n=5 Participants
|
15.67 kg/m^2
STANDARD_DEVIATION 0.551 • n=4 Participants
|
24.54 kg/m^2
STANDARD_DEVIATION 6.625 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536
|
40613 ng.hr/mL
Standard Deviation 9609.6
|
23889 ng.hr/mL
Standard Deviation 5383.8
|
17423 ng.hr/mL
Standard Deviation 3559.7
|
16056 ng.hr/mL
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
22556 ng.hr/mL
Standard Deviation 5792.6
|
18691 ng.hr/mL
Standard Deviation 5489.9
|
16963 ng.hr/mL
Standard Deviation 4948.4
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.
|
11563 ng.hr/mL
Standard Deviation 3106.5
|
7409 ng.hr/mL
Standard Deviation 78.6
|
7428 ng.hr/mL
Standard Deviation 2120.7
|
7392 ng.hr/mL
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
7929 ng.hr/mL
Standard Deviation 3502.6
|
9130 ng.hr/mL
Standard Deviation 1338.3
|
7285 ng.hr/mL
Standard Deviation 3626.0
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536
|
44820 ng.hr/mL
Standard Deviation 11680.7
|
26411 ng.hr/mL
Standard Deviation 6703.1
|
18686 ng.hr/mL
Standard Deviation 3720.4
|
16563 ng.hr/mL
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
23792 ng.hr/mL
Standard Deviation 6157.0
|
19543 ng.hr/mL
Standard Deviation 6181.1
|
17771 ng.hr/mL
Standard Deviation 5263.1
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II
|
19188 ng.hr/mL
Standard Deviation 6766.0
|
10596 ng.hr/mL
Standard Deviation 1168.8
|
12532 ng.hr/mL
Standard Deviation 3905.3
|
8961 ng.hr/mL
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
11387 ng.hr/mL
Standard Deviation 5440.7
|
14230 ng.hr/mL
Standard Deviation 3419.6
|
9477 ng.hr/mL
Standard Deviation 4659.6
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for TAK-536
|
5699 ng/mL
Standard Deviation 1346.1
|
3245 ng/mL
Standard Deviation 106.1
|
2512 ng/mL
Standard Deviation 701.6
|
2810 ng/mL
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
3858 ng/mL
Standard Deviation 1363.0
|
2960 ng/mL
Standard Deviation 364.3
|
3320 ng/mL
Standard Deviation 656.0
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II
|
736 ng/mL
Standard Deviation 241.6
|
480 ng/mL
Standard Deviation 74.2
|
535 ng/mL
Standard Deviation 200.2
|
514 ng/mL
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
561 ng/mL
Standard Deviation 211.7
|
561 ng/mL
Standard Deviation 40.3
|
488 ng/mL
Standard Deviation 212.2
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) for TAK-536
|
2.00 hr
Full Range 0.8819 • Interval 2.0 to 4.0
|
2.01 hr
Full Range 0.0118 • Interval 2.0 to 2.02
|
2.00 hr
Full Range 0.4082 • Interval 1.0 to 2.0
|
2.00 hr
Full Range NA
Standard deviation or range cannot be calculated for 1 participant.
|
2.00 hr
Full Range 2.2043 • Interval 1.05 to 6.0
|
2.00 hr
Full Range 0.0096 • Interval 1.98 to 2.0
|
1.00 hr
Full Range 0.0000 • Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II
|
6.00 hr
Full Range 1.4227 • Interval 4.0 to 8.0
|
5.00 hr
Full Range 1.4142 • Interval 4.0 to 6.0
|
6.00 hr
Full Range 0.8256 • Interval 4.0 to 6.1
|
6.00 hr
Full Range NA
Standard deviation or range cannot be calculated for 1 participant.
|
4.03 hr
Full Range 1.9890 • Interval 4.0 to 8.0
|
4.00 hr
Full Range 2.3094 • Interval 4.0 to 8.0
|
6.0 hr
Full Range 0.0000 • Interval 6.0 to 6.0
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (T1/2) for TAK-536
|
7.35 hr
Standard Deviation 1.083
|
7.74 hr
Standard Deviation 0.621
|
5.76 hr
Standard Deviation 1.158
|
5.07 hr
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
5.75 hr
Standard Deviation 0.760
|
5.37 hr
Standard Deviation 0.922
|
4.59 hr
Standard Deviation 1.627
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II
|
16.60 hr
Standard Deviation 6.870
|
12.78 hr
Standard Deviation 2.915
|
14.00 hr
Standard Deviation 2.414
|
8.50 hr
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
11.56 hr
Standard Deviation 3.314
|
13.97 hr
Standard Deviation 2.983
|
10.35 hr
Standard Deviation 2.770
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 Participants
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) for TAK-536
|
1.52 L/hr
Standard Deviation 0.414
|
1.88 L/hr
Standard Deviation 0.477
|
1.78 L/hr
Standard Deviation 0.411
|
2.90 L/hr
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
1.43 L/hr
Standard Deviation 0.427
|
0.87 L/hr
Standard Deviation 0.232
|
0.54 L/hr
Standard Deviation 0.134
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=3 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
|
10.65 mg
Standard Deviation 4.673
|
4.56 mg
Standard Deviation 1.029
|
2.89 mg
Standard Deviation 0.936
|
4.59 mg
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
3.63 mg
Standard Deviation 2.125
|
1.27 mg
Standard Deviation 0.580
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=3 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
|
6.60 mg
Standard Deviation 5.149
|
2.93 mg
Standard Deviation 0.582
|
2.73 mg
Standard Deviation 1.528
|
4.43 mg
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
2.77 mg
Standard Deviation 1.197
|
1.48 mg
Standard Deviation 0.284
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Fe=\[Ae(0-24)/dose\]×100 (molecular weight adjusted for metabolites.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=3 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
|
16.65 percent
Standard Deviation 7.302
|
9.50 percent
Standard Deviation 2.144
|
9.04 percent
Standard Deviation 2.925
|
9.57 percent
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
11.36 percent
Standard Deviation 6.639
|
7.94 percent
Standard Deviation 3.622
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Fe=\[Ae(0-24)/dose\]×100 (molecular weight adjusted for metabolites.
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=3 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
|
11.01 percent
Standard Deviation 8.581
|
6.55 percent
Standard Deviation 1.293
|
9.11 percent
Standard Deviation 5.094
|
9.85 percent
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
9.22 percent
Standard Deviation 3.991
|
9.89 percent
Standard Deviation 1.896
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
|
0.28 L/hr
Standard Deviation 0.130
|
0.22 L/hr
Standard Deviation 0.051
|
0.17 L/hr
Standard Deviation 0.077
|
0.29 L/hr
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
0.15 L/hr
Standard Deviation 0.069
|
0.07 L/hr
Standard Deviation 0.011
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.
Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Outcome measures
| Measure |
Cohort 1: Healthy Adults
n=9 Participants
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg
n=2 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg
n=6 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 60 mg
n=1 Participants
Azilsartan medoxomil 60 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 40 mg
n=4 Participants
Azilsartan medoxomil 40 mg, tablets, orally, one day only
|
Cohort 2: Children (≥6 to <12 Years Old) 20 mg
n=3 Participants
Azilsartan medoxomil 20 mg, tablets, orally, one day only
|
Cohort 3: Children (≥1 to <6 Years Old)
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
|
0.55 L/hr
Standard Deviation 0.309
|
0.37 L/hr
Standard Deviation 0.084
|
0.34 L/hr
Standard Deviation 0.146
|
0.60 L/hr
Standard Deviation NA
Standard deviation can not be calculated for 1 participant.
|
0.36 L/hr
Standard Deviation 0.099
|
0.16 L/hr
Standard Deviation 0.022
|
—
|
Adverse Events
Cohort 1: Healthy Adults
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: Children (≥1 to <6 Years Old)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Healthy Adults
n=9 participants at risk
Azilsartan medoxomil 80 mg, tablets, orally, one day only
|
Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg
n=9 participants at risk
Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to \< 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
|
Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg
n=8 participants at risk
Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to \< 40 kg received a 20 mg dose, participants 40 to \< 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
|
Cohort 3: Children (≥1 to <6 Years Old)
n=3 participants at risk
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
|
|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Infusion site pain
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infected bites
|
11.1%
1/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • A treatment-emergent adverse event (TEAE) had an onset occurring after the first dose of study medication and within 14 days after the last dose of study medication or, if an SAE, within 30 days after last dose of study medication.
At each visit the investigator assessed whether any subjective adverse events have occurred and had to document any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER