Trial Outcomes & Findings for A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants (NCT NCT03085836)
NCT ID: NCT03085836
Last Updated: 2019-01-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Results posted on
2019-01-30
Participant Flow
Participants took part in the study at 1 investigative site in China from 19 April 2017 to 17 August 2017.
Healthy Chinese participants were enrolled in this study to receive treatment in one of the 3 treatment groups: TAK-438 10 milligram (mg) once daily or TAK-438 20 mg once daily or TAK-438-20 mg twice daily.
Participant milestones
| Measure |
TAK-438 10 mg Once Daily
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
10
|
|
Overall Study
COMPLETED
|
12
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Baseline characteristics by cohort
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.2 years
STANDARD_DEVIATION 2.95 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
23.9 years
STANDARD_DEVIATION 3.99 • n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
27.2 years
STANDARD_DEVIATION 4.83 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
25.4 years
STANDARD_DEVIATION 4.04 • n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
5 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
4 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
15 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
6 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
6 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
18 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
11 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
10 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
33 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Region of Enrollment
China
|
12 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
11 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
10 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
33 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Height
|
166.35 centimeter (cm)
STANDARD_DEVIATION 8.426 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
169.59 centimeter (cm)
STANDARD_DEVIATION 7.672 • n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
164.31 centimeter (cm)
STANDARD_DEVIATION 9.377 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
166.81 centimeter (cm)
STANDARD_DEVIATION 8.498 • n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Weight
|
62.63 kilogram (kg)
STANDARD_DEVIATION 7.601 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
66.05 kilogram (kg)
STANDARD_DEVIATION 8.501 • n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
61.66 kilogram (kg)
STANDARD_DEVIATION 6.449 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
63.47 kilogram (kg)
STANDARD_DEVIATION 7.597 • n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Body mass index (BMI)
|
22.63 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.086 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
22.89 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.711 • n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
22.88 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.110 • n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
22.79 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.918 • n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Smoking classification
Never smoked
|
12 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
11 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
10 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
33 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Alcohol consumption
Never drank
|
12 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
11 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
10 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
33 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Caffeine consumption
Had no caffeine consumption
|
12 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
11 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
10 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
33 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*1/*1
|
5 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
4 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
4 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
13 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*1/*2
|
4 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
6 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
5 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
15 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*1/*3
|
1 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
1 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*2/*2
|
1 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
1 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
2 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*2/*3
|
1 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
1 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
2 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*3/*3
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=7 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=5 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
0 Participants
n=4 Participants • The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
9.148 nanogram per milliliter (ng/mL)
Standard Deviation 2.9972
|
18.18 nanogram per milliliter (ng/mL)
Standard Deviation 4.4973
|
25.23 nanogram per milliliter (ng/mL)
Standard Deviation 10.017
|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
38.32 nanogram per milliliter (ng/mL)
Standard Deviation 8.6143
|
67.95 nanogram per milliliter (ng/mL)
Standard Deviation 23.388
|
59.02 nanogram per milliliter (ng/mL)
Standard Deviation 18.443
|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
2.840 nanogram per milliliter (ng/mL)
Standard Deviation 1.0442
|
5.155 nanogram per milliliter (ng/mL)
Standard Deviation 2.7868
|
4.879 nanogram per milliliter (ng/mL)
Standard Deviation 2.2426
|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
15.42 nanogram per milliliter (ng/mL)
Standard Deviation 3.7788
|
25.63 nanogram per milliliter (ng/mL)
Standard Deviation 7.8650
|
25.67 nanogram per milliliter (ng/mL)
Standard Deviation 5.9219
|
|
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
28.29 nanogram per milliliter (ng/mL)
Standard Deviation 5.0563
|
60.67 nanogram per milliliter (ng/mL)
Standard Deviation 16.499
|
42.28 nanogram per milliliter (ng/mL)
Standard Deviation 9.1174
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
1.750 hour
Interval 1.0 to 4.02
|
2.000 hour
Interval 0.75 to 4.0
|
2.500 hour
Interval 0.75 to 4.0
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
1.500 hour
Interval 0.75 to 2.0
|
1.500 hour
Interval 0.75 to 3.0
|
2.000 hour
Interval 1.0 to 4.0
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
4.010 hour
Interval 3.0 to 10.0
|
6.000 hour
Interval 3.0 to 10.0
|
10.00 hour
Interval 3.0 to 12.0
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
1.750 hour
Interval 1.0 to 2.0
|
2.000 hour
Interval 1.5 to 3.0
|
2.000 hour
Interval 1.5 to 4.0
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
1.500 hour
Interval 1.0 to 2.0
|
1.500 hour
Interval 1.5 to 3.0
|
2.000 hour
Interval 1.5 to 3.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
84.38 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 29.197
|
188.1 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 43.066
|
226.8 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 67.128
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
305.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 88.227
|
617.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 213.56
|
578.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 144.15
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
52.97 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 22.843
|
106.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 74.306
|
117.8 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 41.170
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
92.83 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 34.769
|
178.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 64.779
|
193.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 56.808
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
132.5 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 44.602
|
307.5 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 89.884
|
240.8 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 82.555
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
74.91 h*ng/mL
Standard Deviation 24.835
|
168.6 h*ng/mL
Standard Deviation 37.455
|
154.8 h*ng/mL
Standard Deviation 38.920
|
|
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
251.4 h*ng/mL
Standard Deviation 77.758
|
528.8 h*ng/mL
Standard Deviation 182.62
|
344.1 h*ng/mL
Standard Deviation 91.089
|
|
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
31.77 h*ng/mL
Standard Deviation 18.646
|
79.07 h*ng/mL
Standard Deviation 56.206
|
41.55 h*ng/mL
Standard Deviation 19.189
|
|
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
87.98 h*ng/mL
Standard Deviation 31.136
|
169.2 h*ng/mL
Standard Deviation 59.474
|
149.1 h*ng/mL
Standard Deviation 36.714
|
|
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
127.1 h*ng/mL
Standard Deviation 43.648
|
296.0 h*ng/mL
Standard Deviation 86.359
|
192.8 h*ng/mL
Standard Deviation 57.176
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
7.879 hour
Standard Deviation 1.2352
|
6.996 hour
Standard Deviation 1.0110
|
7.116 hour
Standard Deviation 0.71638
|
|
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
10.82 hour
Standard Deviation 4.0923
|
8.256 hour
Standard Deviation 1.2964
|
8.385 hour
Standard Deviation 0.73316
|
|
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
10.52 hour
Standard Deviation 4.3311
|
10.37 hour
Standard Deviation 2.9973
|
12.29 hour
Standard Deviation 4.0538
|
|
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
6.695 hour
Standard Deviation 1.3786
|
6.335 hour
Standard Deviation 1.1833
|
6.791 hour
Standard Deviation 0.89228
|
|
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
4.753 hour
Standard Deviation 2.4430
|
5.698 hour
Standard Deviation 1.2625
|
5.521 hour
Standard Deviation 2.2225
|
PRIMARY outcome
Timeframe: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
TAK-438F
|
11.01 ng/mL
Standard Deviation 3.4863
|
23.43 ng/mL
Standard Deviation 6.1433
|
37.88 ng/mL
Standard Deviation 10.910
|
|
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-I
|
43.39 ng/mL
Standard Deviation 9.6528
|
79.85 ng/mL
Standard Deviation 22.119
|
59.55 ng/mL
Standard Deviation 15.512
|
|
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-II
|
3.558 ng/mL
Standard Deviation 1.4983
|
6.554 ng/mL
Standard Deviation 2.6078
|
9.174 ng/mL
Standard Deviation 2.8376
|
|
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-III
|
16.62 ng/mL
Standard Deviation 4.1919
|
30.15 ng/mL
Standard Deviation 7.3228
|
33.01 ng/mL
Standard Deviation 6.1638
|
|
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-IV-Sul
|
25.33 ng/mL
Standard Deviation 3.6619
|
54.08 ng/mL
Standard Deviation 13.927
|
39.74 ng/mL
Standard Deviation 7.1405
|
PRIMARY outcome
Timeframe: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
TAK-438F
|
1.500 hour
Interval 0.75 to 3.02
|
2.000 hour
Interval 0.75 to 3.0
|
3.000 hour
Interval 0.75 to 4.0
|
|
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-I
|
1.500 hour
Interval 0.75 to 2.02
|
1.000 hour
Interval 0.75 to 2.0
|
2.500 hour
Interval 1.0 to 10.0
|
|
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-II
|
4.000 hour
Interval 3.0 to 6.0
|
3.000 hour
Interval 3.0 to 10.0
|
3.500 hour
Interval 0.0 to 10.0
|
|
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-III
|
1.750 hour
Interval 1.0 to 3.0
|
2.000 hour
Interval 1.5 to 3.0
|
3.000 hour
Interval 1.5 to 4.0
|
|
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-IV-Sul
|
2.000 hour
Interval 1.0 to 3.0
|
1.500 hour
Interval 1.5 to 2.0
|
3.000 hour
Interval 1.5 to 4.0
|
PRIMARY outcome
Timeframe: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
TAK-438F
|
93.90 h*ng/mL
Standard Deviation 28.053
|
212.7 h*ng/mL
Standard Deviation 57.214
|
273.4 h*ng/mL
Standard Deviation 71.830
|
|
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-I
|
285.5 h*ng/mL
Standard Deviation 77.884
|
581.1 h*ng/mL
Standard Deviation 198.14
|
435.3 h*ng/mL
Standard Deviation 92.064
|
|
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-II
|
46.31 h*ng/mL
Standard Deviation 24.298
|
105.5 h*ng/mL
Standard Deviation 51.688
|
100.4 h*ng/mL
Standard Deviation 27.966
|
|
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-III
|
95.94 h*ng/mL
Standard Deviation 29.719
|
194.6 h*ng/mL
Standard Deviation 53.749
|
222.6 h*ng/mL
Standard Deviation 49.670
|
|
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-IV-Sul
|
117.1 h*ng/mL
Standard Deviation 37.489
|
256.1 h*ng/mL
Standard Deviation 62.786
|
225.7 h*ng/mL
Standard Deviation 52.675
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
448.5 microgram (mcg)
Standard Deviation 159.06
|
890.3 microgram (mcg)
Standard Deviation 243.24
|
1478 microgram (mcg)
Standard Deviation 405.32
|
|
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
176.6 microgram (mcg)
Standard Deviation 79.813
|
253.1 microgram (mcg)
Standard Deviation 118.69
|
211.2 microgram (mcg)
Standard Deviation 124.21
|
|
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
0.000 microgram (mcg)
Standard Deviation 0.0000
|
0.000 microgram (mcg)
Standard Deviation 0.0000
|
0.000 microgram (mcg)
Standard Deviation 0.0000
|
|
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
0.000 microgram (mcg)
Standard Deviation 0.0000
|
0.000 microgram (mcg)
Standard Deviation 0.0000
|
0.5120 microgram (mcg)
Standard Deviation 1.6191
|
|
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
205.4 microgram (mcg)
Standard Deviation 61.587
|
422.1 microgram (mcg)
Standard Deviation 143.24
|
387.1 microgram (mcg)
Standard Deviation 142.06
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
4.485 percentage of drug
Standard Deviation 1.5906
|
4.448 percentage of drug
Standard Deviation 1.2093
|
7.399 percentage of drug
Standard Deviation 2.0335
|
|
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
1.760 percentage of drug
Standard Deviation 0.79678
|
1.262 percentage of drug
Standard Deviation 0.59122
|
1.053 percentage of drug
Standard Deviation 0.61992
|
|
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
|
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.002460 percentage of drug
Standard Deviation 0.0077792
|
|
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
1.609 percentage of drug
Standard Deviation 0.48258
|
1.650 percentage of drug
Standard Deviation 0.56108
|
1.513 percentage of drug
Standard Deviation 0.55536
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
TAK-438F
|
5.443 liter per hour (L/h)
Standard Deviation 1.0398
|
4.922 liter per hour (L/h)
Standard Deviation 1.4362
|
6.733 liter per hour (L/h)
Standard Deviation 1.3109
|
|
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-I
|
0.6235 liter per hour (L/h)
Standard Deviation 0.16437
|
0.4465 liter per hour (L/h)
Standard Deviation 0.24193
|
0.3753 liter per hour (L/h)
Standard Deviation 0.19679
|
|
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-II
|
0.000 liter per hour (L/h)
Standard Deviation 0.0000
|
0.000 liter per hour (L/h)
Standard Deviation 0.0000
|
0.000 liter per hour (L/h)
Standard Deviation 0.0000
|
|
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-III
|
0.000 liter per hour (L/h)
Standard Deviation 0.0000
|
0.000 liter per hour (L/h)
Standard Deviation 0.0000
|
0.001820 liter per hour (L/h)
Standard Deviation 0.0057553
|
|
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
M-IV-Sul
|
1.748 liter per hour (L/h)
Standard Deviation 0.65948
|
1.527 liter per hour (L/h)
Standard Deviation 0.77444
|
1.707 liter per hour (L/h)
Standard Deviation 0.47416
|
PRIMARY outcome
Timeframe: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-III
|
0.000 mcg
Standard Deviation 0.0000
|
0.000 mcg
Standard Deviation 0.0000
|
0.000 mcg
Standard Deviation 0.0000
|
|
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-IV-Sul
|
205.2 mcg
Standard Deviation 52.172
|
390.7 mcg
Standard Deviation 99.477
|
446.4 mcg
Standard Deviation 139.39
|
|
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
TAK-438F
|
437.7 mcg
Standard Deviation 121.93
|
859.9 mcg
Standard Deviation 155.66
|
1327 mcg
Standard Deviation 274.04
|
|
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-I
|
224.3 mcg
Standard Deviation 79.531
|
354.1 mcg
Standard Deviation 165.88
|
340.9 mcg
Standard Deviation 181.71
|
|
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-II
|
0.000 mcg
Standard Deviation 0.0000
|
0.000 mcg
Standard Deviation 0.0000
|
0.000 mcg
Standard Deviation 0.0000
|
PRIMARY outcome
Timeframe: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
TAK-438F
|
4.377 percentage of drug
Standard Deviation 1.2193
|
4.299 percentage of drug
Standard Deviation 0.77678
|
6.634 percentage of drug
Standard Deviation 1.3737
|
|
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-I
|
2.236 percentage of drug
Standard Deviation 0.79323
|
1.765 percentage of drug
Standard Deviation 0.82755
|
1.700 percentage of drug
Standard Deviation 0.90664
|
|
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-II
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
|
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-III
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
0.000 percentage of drug
Standard Deviation 0.0000
|
|
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-IV-Sul
|
1.605 percentage of drug
Standard Deviation 0.40853
|
1.528 percentage of drug
Standard Deviation 0.38946
|
1.748 percentage of drug
Standard Deviation 0.54499
|
PRIMARY outcome
Timeframe: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dosePopulation: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
Outcome measures
| Measure |
TAK-438 10 mg Once Daily
n=12 Participants
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 Participants
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 Participants
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-IV-Sul
|
1.931 L/h
Standard Deviation 0.79907
|
1.614 L/h
Standard Deviation 0.58643
|
2.067 L/h
Standard Deviation 0.70761
|
|
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
TAK-438F
|
4.848 L/h
Standard Deviation 1.2372
|
4.251 L/h
Standard Deviation 1.1565
|
4.977 L/h
Standard Deviation 0.71952
|
|
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-I
|
0.8126 L/h
Standard Deviation 0.26393
|
0.6207 L/h
Standard Deviation 0.22632
|
0.7943 L/h
Standard Deviation 0.39001
|
|
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-II
|
0.000 L/h
Standard Deviation 0.0000
|
0.000 L/h
Standard Deviation 0.0000
|
0.000 L/h
Standard Deviation 0.0000
|
|
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
M-III
|
0.000 L/h
Standard Deviation 0.0000
|
0.000 L/h
Standard Deviation 0.0000
|
0.000 L/h
Standard Deviation 0.0000
|
Adverse Events
TAK-438 10 mg Once Daily
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TAK-438 20 mg Once Daily
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TAK-438 20 mg Twice Daily
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-438 10 mg Once Daily
n=12 participants at risk
TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Once Daily
n=11 participants at risk
TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.
|
TAK-438 20 mg Twice Daily
n=10 participants at risk
TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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 pain upper
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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 pain
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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
Urinary tract infection
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cells urine positive
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.2%
2/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Red blood cells urine positive
|
16.7%
2/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
2/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Neutrophil count increased
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count increased
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Glucose urine present
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Protein urine present
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18)
At each visit the investigator had to document any occurrence of adverse events and 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 Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER