Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants (NCT NCT02389881)
NCT ID: NCT02389881
Last Updated: 2017-02-23
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14
Results posted on
2017-02-23
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 20 February 2015 to 3 December 2015.
Healthy non-elderly were enrolled in 1 of 5 treatment groups, TAK-058 25 mg, 75 mg, 150 mg, 300 mg or placebo. Healthy elderly participants were enrolled in 1 of 2 treatment groups, TAK-058 25 mg or placebo.
Participant milestones
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
8
|
2
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
n=8 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
n=2 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 6.77 • n=93 Participants
|
36.2 years
STANDARD_DEVIATION 11.65 • n=4 Participants
|
42.2 years
STANDARD_DEVIATION 11.23 • n=27 Participants
|
68.2 years
STANDARD_DEVIATION 1.83 • n=483 Participants
|
41.0 years
STANDARD_DEVIATION 15.39 • n=36 Participants
|
40.9 years
STANDARD_DEVIATION 13.67 • n=10 Participants
|
72.5 years
STANDARD_DEVIATION 2.12 • n=115 Participants
|
46.6 years
STANDARD_DEVIATION 15.56 • n=40 Participants
|
|
Gender
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
12 Participants
n=40 Participants
|
|
Gender
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
28 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
28 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
14 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
26 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
40 Participants
n=40 Participants
|
|
Height
|
171.5 cm
STANDARD_DEVIATION 10.17 • n=93 Participants
|
171.0 cm
STANDARD_DEVIATION 7.95 • n=4 Participants
|
173.2 cm
STANDARD_DEVIATION 10.23 • n=27 Participants
|
173.7 cm
STANDARD_DEVIATION 12.21 • n=483 Participants
|
171.0 cm
STANDARD_DEVIATION 9.42 • n=36 Participants
|
176.1 cm
STANDARD_DEVIATION 4.52 • n=10 Participants
|
154.5 cm
STANDARD_DEVIATION 2.12 • n=115 Participants
|
172.0 cm
STANDARD_DEVIATION 9.45 • n=40 Participants
|
|
Weight
|
76.15 kg
STANDARD_DEVIATION 9.291 • n=93 Participants
|
75.63 kg
STANDARD_DEVIATION 10.397 • n=4 Participants
|
83.55 kg
STANDARD_DEVIATION 12.902 • n=27 Participants
|
83.08 kg
STANDARD_DEVIATION 10.778 • n=483 Participants
|
74.17 kg
STANDARD_DEVIATION 15.687 • n=36 Participants
|
79.63 kg
STANDARD_DEVIATION 9.721 • n=10 Participants
|
68.35 kg
STANDARD_DEVIATION 5.869 • n=115 Participants
|
78.23 kg
STANDARD_DEVIATION 11.322 • n=40 Participants
|
|
Body Mass Index (BMI)
|
25.87 kg/m^2
STANDARD_DEVIATION 1.742 • n=93 Participants
|
25.80 kg/m^2
STANDARD_DEVIATION 2.392 • n=4 Participants
|
27.68 kg/m^2
STANDARD_DEVIATION 1.451 • n=27 Participants
|
27.48 kg/m^2
STANDARD_DEVIATION 1.094 • n=483 Participants
|
25.17 kg/m^2
STANDARD_DEVIATION 3.463 • n=36 Participants
|
25.66 kg/m^2
STANDARD_DEVIATION 2.942 • n=10 Participants
|
28.60 kg/m^2
STANDARD_DEVIATION 1.697 • n=115 Participants
|
26.36 kg/m^2
STANDARD_DEVIATION 2.416 • n=40 Participants
|
|
Smoking Classification
Never Smoked
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
34 Participants
n=40 Participants
|
|
Smoking Classification
Current Smoker
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
|
Caffeine Consumption
Yes
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
20 Participants
n=40 Participants
|
|
Caffeine Consumption
No
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
20 Participants
n=40 Participants
|
|
Alcohol Consumption
Never Drunk
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
20 Participants
n=40 Participants
|
|
Alcohol Consumption
Current Drinker
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
|
Alcohol Consumption
Ex-drinker
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
|
Reproductive Status
Postmenopausal
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
|
Reproductive Status
Surgically Sterile
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
|
Reproductive Status
Female of Childbearing Potential
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Reproductive Status
Not Applicable (Participant is Male)
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
28 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14Population: Safety Set, all enrolled participants who received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
n=8 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
n=2 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event
|
50.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
PRIMARY outcome
Timeframe: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14Population: Safety Set, all enrolled participants who received at least 1 dose of study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
n=8 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
n=2 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14Population: Safety Set, all enrolled participants who received at least 1 dose of study drug.
The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
n=8 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
n=2 Participants
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
Pulse Rate
|
0.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
Any Markedly Abnormal Vital Sign
|
16.7 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
12.5 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
Systolic Blood Pressure
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
Diastolic Blood Pressure
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose
Temperature
|
0.0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdosePopulation: Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Mean Cmax: Maximum Observed Plasma Concentration for TAK-058
Day 1
|
1076.0 ng/mL
Standard Deviation 272.66
|
2085.0 ng/mL
Standard Deviation 492.70
|
2366.7 ng/mL
Standard Deviation 738.88
|
811.8 ng/mL
Standard Deviation 179.48
|
3361.7 ng/mL
Standard Deviation 479.85
|
—
|
—
|
|
Mean Cmax: Maximum Observed Plasma Concentration for TAK-058
Day 10
|
1035.0 ng/mL
Standard Deviation 404.58
|
2021.7 ng/mL
Standard Deviation 577.91
|
2158.3 ng/mL
Standard Deviation 560.69
|
886.2 ng/mL
Standard Deviation 332.50
|
NA ng/mL
Standard Deviation NA
This cohort received a single dose on Day 1 only, therefore Day 10 analysis not applicable.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and at multiple time points (up to 72 hours) postdosePopulation: Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.
AUClast is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058
|
4414.6 ng*hr/mL
Standard Deviation 1461.59
|
9223.2 ng*hr/mL
Standard Deviation 5433.05
|
12262.6 ng*hr/mL
Standard Deviation 4671.88
|
4326.8 ng*hr/mL
Standard Deviation 1287.86
|
15143.1 ng*hr/mL
Standard Deviation 3471.42
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 predose and at multiple time points (up to 24 hours) postdosePopulation: Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.
AUC24 is measure of area under the curve from time 0 to 24 hours postdose.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 Participants
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058
|
4372.6 ng*hr/mL
Standard Deviation 1436.73
|
8862.9 ng*hr/mL
Standard Deviation 4782.64
|
12013.0 ng*hr/mL
Standard Deviation 4495.56
|
4244.9 ng*hr/mL
Standard Deviation 1243.28
|
14852.3 ng*hr/mL
Standard Deviation 3348.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 predose and at multiple time points (up to 24 hours) postdosePopulation: Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.
Area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval.
Outcome measures
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 Participants
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 Participants
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 Participants
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058
|
4295.3 ng*hr/mL
Standard Deviation 2208.92
|
8325.4 ng*hr/mL
Standard Deviation 4642.29
|
11905.9 ng*hr/mL
Standard Deviation 4447.14
|
4539.2 ng*hr/mL
Standard Deviation 1509.66
|
—
|
—
|
—
|
Adverse Events
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 Elderly Healthy: TAK-058 25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 Elderly Healthy: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 Non-elderly Healthy: TAK-058 25 mg
n=6 participants at risk
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 2 Non-elderly Healthy: TAK-058 75 mg
n=6 participants at risk
TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 3 Non-elderly Healthy: TAK-058 150 mg
n=6 participants at risk
TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: TAK-058 25 mg
n=6 participants at risk
TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
|
Cohort 5 Non-elderly Healthy: TAK-058 300 mg
n=6 participants at risk
TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
|
Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo
n=8 participants at risk
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
|
Cohort 4 Elderly Healthy: Placebo
n=2 participants at risk
TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Infrequent bowel movements
|
33.3%
2/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 distension
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Constipation
|
16.7%
1/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Haemorrhoidal haemorrhage
|
16.7%
1/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Salivary hypersecretion
|
16.7%
1/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
1/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Myalgia
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Presyncope
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
1/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Skin irritation
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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
Application site irritation
|
0.00%
0/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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%
0/2 • Collection of AEs commenced from the time that the participant was first administered study medication on Day 1 until 30 days following last dose (up to Day 40 for Cohorts 1-4 and up to Day 30 for Cohort 5).
At each visit the investigator had to document any occurrence of adverse events and 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