Trial Outcomes & Findings for A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants (NCT NCT03228433)
NCT ID: NCT03228433
Last Updated: 2019-09-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Baseline Up to Day 184
Results posted on
2019-09-09
Participant Flow
Participants took part in the study at single site in the United States from 21 July 2017 to 12 May 2018.
Healthy participants were randomized to receive TAK-418 or matching placebo in Cohorts 1 to 5.
Participant milestones
| Measure |
Cohorts 1-5: Placebo
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
TAK-418 5 milligram (mg), capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohorts 1-5: Placebo
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
TAK-418 5 milligram (mg), capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Positive alcohol test
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 10.80 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 10.60 • n=4 Participants
|
33.2 years
STANDARD_DEVIATION 6.49 • n=21 Participants
|
38.7 years
STANDARD_DEVIATION 10.03 • n=8 Participants
|
36.5 years
STANDARD_DEVIATION 9.43 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
|
Weight
|
81.2 kilogram (kg)
STANDARD_DEVIATION 12.34 • n=5 Participants
|
76.0 kilogram (kg)
STANDARD_DEVIATION 13.58 • n=7 Participants
|
81.8 kilogram (kg)
STANDARD_DEVIATION 6.83 • n=5 Participants
|
82.5 kilogram (kg)
STANDARD_DEVIATION 4.22 • n=4 Participants
|
80.0 kilogram (kg)
STANDARD_DEVIATION 12.43 • n=21 Participants
|
76.1 kilogram (kg)
STANDARD_DEVIATION 15.23 • n=8 Participants
|
79.8 kilogram (kg)
STANDARD_DEVIATION 11.0 • n=8 Participants
|
|
Height
|
173.4 centimeter (cm)
STANDARD_DEVIATION 8.66 • n=5 Participants
|
171.0 centimeter (cm)
STANDARD_DEVIATION 8.10 • n=7 Participants
|
174.8 centimeter (cm)
STANDARD_DEVIATION 3.19 • n=5 Participants
|
172.5 centimeter (cm)
STANDARD_DEVIATION 5.09 • n=4 Participants
|
181.2 centimeter (cm)
STANDARD_DEVIATION 5.08 • n=21 Participants
|
171.5 centimeter (cm)
STANDARD_DEVIATION 11.78 • n=8 Participants
|
174.0 centimeter (cm)
STANDARD_DEVIATION 7.89 • n=8 Participants
|
|
Body mass index (BMI)
|
26.94 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.065 • n=5 Participants
|
25.82 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.440 • n=7 Participants
|
26.83 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.835 • n=5 Participants
|
27.83 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.414 • n=4 Participants
|
24.32 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.988 • n=21 Participants
|
25.73 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.992 • n=8 Participants
|
26.32 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.864 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline Up to Day 184Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
4 participants
|
2 participants
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline Up to Day 184Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Due to an Adverse Event (AE)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline Up to Day 184Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline Up to Day 184Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline Up to day 184Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Diastolic blood pressure less than (<) 50 mmHg
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Systolic blood pressure < 85 mmHg
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Temperature < 35.6 degrees celsius (°C)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Temperature greater than (>) 37.7 (°C)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline Up to Day 14Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=10 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
ECG ventricular rate(Beats/ minute)
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
QT interval (Milliseconds)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=5 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=6 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)
|
77.3 hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 47.1
|
290.4 hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.8
|
649.4 hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 8.5
|
616.2 hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.1
|
674.1 hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.0
|
1576.3 hour nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 33.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=5 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=6 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F
|
84.9 h*ng/mL
Geometric Coefficient of Variation 47.4
|
296.3 h*ng/mL
Geometric Coefficient of Variation 22.1
|
659.6 h*ng/mL
Geometric Coefficient of Variation 8.0
|
626.0 h*ng/mL
Geometric Coefficient of Variation 22.7
|
681.0 h*ng/mL
Geometric Coefficient of Variation 26.9
|
1519.9 h*ng/mL
Geometric Coefficient of Variation 33.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=5 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=6 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-418F
|
21.54 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 35.9
|
61.90 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 26.6
|
163.64 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 20.9
|
94.93 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 33.8
|
155.32 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 34.3
|
321.52 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 14.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-doseThe pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.
Outcome measures
| Measure |
Cohorts 1-5: Placebo
n=6 Participants
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 Participants
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 Participants
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=5 Participants
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=6 Participants
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 Participants
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F
|
1.000 hour
Interval 0.98 to 1.02
|
1.000 hour
Interval 1.0 to 2.0
|
1.000 hour
Interval 0.5 to 1.0
|
3.000 hour
Interval 1.5 to 3.02
|
1.250 hour
Interval 1.0 to 1.52
|
1.000 hour
Interval 1.0 to 1.0
|
—
|
Adverse Events
Cohorts 1-5: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: TAK-418 5 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: TAK-418 15 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3A: TAK-418 30 mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3B: TAK-418 30 mg Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: TAK-418 40 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5: TAK-418 60 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohorts 1-5: Placebo
n=10 participants at risk
TAK-418 placebo-matching, capsule, orally, once on Day 1.
|
Cohort 1: TAK-418 5 mg
n=6 participants at risk
TAK-418 5 mg, capsule, orally, once on Day 1.
|
Cohort 2: TAK-418 15 mg
n=6 participants at risk
TAK-418 15 mg, capsule, orally, once on Day 1.
|
Cohort 3A: TAK-418 30 mg Fasted
n=6 participants at risk
TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1.
|
Cohort 3B: TAK-418 30 mg Fed
n=5 participants at risk
TAK-418 30 mg, capsule, in fed state, orally, once on Day 1.
|
Cohort 4: TAK-418 40 mg
n=6 participants at risk
TAK-418 40 mg, capsule, orally, once on Day 1.
|
Cohort 5: TAK-418 60 mg
n=6 participants at risk
TAK-418 60 mg, capsule, orally, once on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Nausea
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Dental caries
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Vomiting
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Upper respiratory tract infection
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
33.3%
2/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Somnolence
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Nasal congestion
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Dermatitis contact
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Dry skin
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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
Night sweats
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
1/5 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184
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