Trial Outcomes & Findings for A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants (NCT NCT02541669)
NCT ID: NCT02541669
Last Updated: 2020-02-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Results posted on
2020-02-05
Participant Flow
Participants took part in the study at 1 investigative site in China from 17 November 2015 to 17 March 2017.
Healthy Chinese participants were enrolled in the study in 2-parts, Open-label in which participants were allocated equally and randomly to TAK-491 40 milligram (mg) and TAK-491 80 mg and Double-blind in which participants were allocated equally and randomly to 1 of 3 regimens Placebo, TAK-491 40 mg, and TAK-491 80 mg.
Participant milestones
| Measure |
Open Label: TAK-491 40 mg
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: Placebo
TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 40 mg
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|---|
|
Open Label Treatment Period
STARTED
|
8
|
8
|
0
|
0
|
0
|
|
Open Label Treatment Period
COMPLETED
|
8
|
8
|
0
|
0
|
0
|
|
Open Label Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blinded Treatment Period
STARTED
|
0
|
0
|
16
|
16
|
16
|
|
Double-Blinded Treatment Period
COMPLETED
|
0
|
0
|
15
|
16
|
15
|
|
Double-Blinded Treatment Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Open Label: TAK-491 40 mg
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: Placebo
TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 40 mg
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|---|
|
Double-Blinded Treatment Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
The randomized set included all participants who were randomized.
Baseline characteristics by cohort
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: Placebo
n=16 Participants
TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=16 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 4.40 • n=5 Participants • The randomized set included all participants who were randomized.
|
30.3 years
STANDARD_DEVIATION 4.98 • n=7 Participants • The randomized set included all participants who were randomized.
|
33.0 years
STANDARD_DEVIATION 5.07 • n=5 Participants • The randomized set included all participants who were randomized.
|
27.4 years
STANDARD_DEVIATION 4.19 • n=4 Participants • The randomized set included all participants who were randomized.
|
29.7 years
STANDARD_DEVIATION 5.63 • n=21 Participants • The randomized set included all participants who were randomized.
|
29.9 years
STANDARD_DEVIATION 5.19 • n=10 Participants • The randomized set included all participants who were randomized.
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
3 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
1 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
1 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
3 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
11 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
5 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
15 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
15 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
13 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
53 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
8 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
16 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
16 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
16 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
64 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Region of Enrollment
China
|
8 participants
n=5 Participants • The randomized set included all participants who were randomized.
|
8 participants
n=7 Participants • The randomized set included all participants who were randomized.
|
16 participants
n=5 Participants • The randomized set included all participants who were randomized.
|
16 participants
n=4 Participants • The randomized set included all participants who were randomized.
|
16 participants
n=21 Participants • The randomized set included all participants who were randomized.
|
64 participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Height
|
169.9 centimeter (cm)
STANDARD_DEVIATION 6.66 • n=5 Participants • The randomized set included all participants who were randomized.
|
165.3 centimeter (cm)
STANDARD_DEVIATION 6.36 • n=7 Participants • The randomized set included all participants who were randomized.
|
171.0 centimeter (cm)
STANDARD_DEVIATION 6.07 • n=5 Participants • The randomized set included all participants who were randomized.
|
170.4 centimeter (cm)
STANDARD_DEVIATION 5.80 • n=4 Participants • The randomized set included all participants who were randomized.
|
171.9 centimeter (cm)
STANDARD_DEVIATION 6.75 • n=21 Participants • The randomized set included all participants who were randomized.
|
170.2 centimeter (cm)
STANDARD_DEVIATION 6.41 • n=10 Participants • The randomized set included all participants who were randomized.
|
|
Weight
|
66.23 kilogram (kg)
STANDARD_DEVIATION 4.785 • n=5 Participants • The randomized set included all participants who were randomized.
|
59.83 kilogram (kg)
STANDARD_DEVIATION 4.951 • n=7 Participants • The randomized set included all participants who were randomized.
|
64.09 kilogram (kg)
STANDARD_DEVIATION 6.012 • n=5 Participants • The randomized set included all participants who were randomized.
|
64.79 kilogram (kg)
STANDARD_DEVIATION 7.916 • n=4 Participants • The randomized set included all participants who were randomized.
|
65.69 kilogram (kg)
STANDARD_DEVIATION 6.934 • n=21 Participants • The randomized set included all participants who were randomized.
|
64.40 kilogram (kg)
STANDARD_DEVIATION 6.619 • n=10 Participants • The randomized set included all participants who were randomized.
|
|
Body Mass Index (BMI)
|
22.96 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.289 • n=5 Participants • The randomized set included all participants who were randomized.
|
21.94 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.707 • n=7 Participants • The randomized set included all participants who were randomized.
|
21.89 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.143 • n=5 Participants • The randomized set included all participants who were randomized.
|
22.23 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.703 • n=4 Participants • The randomized set included all participants who were randomized.
|
22.16 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.109 • n=21 Participants • The randomized set included all participants who were randomized.
|
22.18 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.382 • n=10 Participants • The randomized set included all participants who were randomized.
|
|
Smoking classification
Never smoked
|
8 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
8 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
14 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
14 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
13 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
57 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Smoking classification
Current smoker
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Smoking classification
Ex-smoker
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
2 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
2 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
3 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
7 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Female Reproductive Status
Having Childbearing Potential
|
3 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
3 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
1 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
1 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
3 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
11 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Female Reproductive Status
Postmenopausal
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Female Reproductive Status
Surgically Sterile
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
0 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
|
Female Reproductive Status
Male Participants
|
5 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
5 Participants
n=7 Participants • The randomized set included all participants who were randomized.
|
15 Participants
n=5 Participants • The randomized set included all participants who were randomized.
|
15 Participants
n=4 Participants • The randomized set included all participants who were randomized.
|
13 Participants
n=21 Participants • The randomized set included all participants who were randomized.
|
53 Participants
n=10 Participants • The randomized set included all participants who were randomized.
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic (PK) set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=16 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
|
2877 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25.0
|
6250 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 20.5
|
2444 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22.5
|
5460 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.4
|
PRIMARY outcome
Timeframe: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK set where Day 10 assessments were available. The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=15 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
|
3070 ng/mL
Geometric Coefficient of Variation 4.6
|
6019 ng/mL
Geometric Coefficient of Variation 29.5
|
2628 ng/mL
Geometric Coefficient of Variation 23.3
|
6226 ng/mL
Geometric Coefficient of Variation 19.9
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=16 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
|
3.03 hour
Interval 2.0 to 6.0
|
2.50 hour
Interval 2.0 to 4.0
|
3.00 hour
Interval 2.0 to 6.03
|
2.50 hour
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK set where Day 10 assessments were available. The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=15 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
|
3.00 hour
Interval 1.0 to 4.0
|
2.52 hour
Interval 2.0 to 6.0
|
3.49 hour
Interval 1.98 to 5.98
|
2.00 hour
Interval 1.98 to 6.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=16 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
|
25905 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.3
|
50359 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 12.1
|
23439 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.6
|
45698 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 32.1
|
PRIMARY outcome
Timeframe: Day 10 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: PK set where Day 10 assessments were available. The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=15 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
|
25087 h*ng/mL
Geometric Coefficient of Variation 21.5
|
45320 h*ng/mL
Geometric Coefficient of Variation 14.7
|
21872 h*ng/mL
Geometric Coefficient of Variation 19.1
|
47993 h*ng/mL
Geometric Coefficient of Variation 31.8
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.
Outcome measures
| Measure |
Open Label: TAK-491 40 mg
n=8 Participants
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 Participants
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: TAK-491 40 mg
n=16 Participants
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=16 Participants
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
|
11.18 hour
Geometric Coefficient of Variation 19.4
|
10.18 hour
Geometric Coefficient of Variation 24.1
|
11.12 hour
Geometric Coefficient of Variation 16.9
|
11.10 hour
Geometric Coefficient of Variation 18.9
|
Adverse Events
Open Label: TAK-491 40 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Open Label: TAK-491 80 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Double-blind: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Double-blind: TAK-491 40 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Double-blind: TAK-491 80 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label: TAK-491 40 mg
n=8 participants at risk
TAK-491 40 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Open Label: TAK-491 80 mg
n=8 participants at risk
TAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
|
Double-blind: Placebo
n=16 participants at risk
TAK-491 placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 40 mg
n=16 participants at risk
TAK-491 40 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
Double-blind: TAK-491 80 mg
n=16 participants at risk
TAK-491 80 mg, tablet, orally, once daily and TAK-491 placebo-matching tablets, orally, once daily on Day 1 and Days 4 to 10 as a double blinded treatment.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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
Nasopharyngitis
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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
Gastrointestinal viral infection
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
25.0%
4/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
25.0%
4/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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 triglycerides increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
18.8%
3/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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
Transaminases increased
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
25.0%
2/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
12.5%
2/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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
Gamma-glutamyltransferase increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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 cholesterol increased
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
12.5%
2/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/8 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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%
0/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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.
|
6.2%
1/16 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (Day 40)
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