Trial Outcomes & Findings for TAK-653 Escalating Single and Multiple Dose Study in Healthy Participants (NCT NCT02561156)
NCT ID: NCT02561156
Last Updated: 2021-03-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
88 participants
Primary outcome timeframe
Baseline up to Day 14
Results posted on
2021-03-03
Participant Flow
Participants took part in the study at 1 investigative site in United Kingdom from 26 August 2015 to 23 September 2017.
Healthy participants were enrolled in this 2 part study to receive TAK-653 as: single rising (SRD) dose of 0.3 milligram (mg), 1 mg, 3 mg , 5 mg, 9 mg or 18 mg in Part 1, and SRD/multiple rising dose (MRD) of 0.3 mg, 1 mg, 3 mg, 6 mg or 9 mg in Part 2.
Participant milestones
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohorts 1-5: Pooled Placebo
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 1: TAK-653 0.3 mg
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
12
|
6
|
6
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
6
|
6
|
6
|
6
|
6
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
6
|
6
|
6
|
5
|
6
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohorts 1-5: Pooled Placebo
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 1: TAK-653 0.3 mg
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Female reproductive status was only assessed in females.
Baseline characteristics by cohort
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohorts 1-5: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
n=6 Participants
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
88 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=88 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
84 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
85 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
69 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=88 Participants
|
|
Region of Enrollment
United Kingdom
|
12 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
88 Participants
n=88 Participants
|
|
Smoking Classification
Never smoked
|
10 Participants
n=12 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
62 Participants
n=88 Participants
|
|
Smoking Classification
Ex-smoker
|
2 Participants
n=12 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
26 Participants
n=88 Participants
|
|
Female Reproductive Status
Surgically sterile
|
1 Participants
n=2 Participants • Female reproductive status was only assessed in females.
|
0 Participants
n=1 Participants • Female reproductive status was only assessed in females.
|
0 Participants
n=1 Participants • Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
1 Participants
n=4 Participants • Female reproductive status was only assessed in females.
|
|
Female Reproductive Status
Female of childbearing potential
|
1 Participants
n=2 Participants • Female reproductive status was only assessed in females.
|
1 Participants
n=1 Participants • Female reproductive status was only assessed in females.
|
1 Participants
n=1 Participants • Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
0 Participants
Female reproductive status was only assessed in females.
|
3 Participants
n=4 Participants • Female reproductive status was only assessed in females.
|
|
Caffeine Consumption
Had caffeine consumption
|
8 Participants
n=12 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
66 Participants
n=88 Participants
|
|
Caffeine Consumption
Had no caffeine consumption
|
4 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
22 Participants
n=88 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 14Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
41.7 percentage of participants
|
66.7 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
83.3 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 31Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Who Experience at Least One TEAE
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
100.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 14Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 31Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Who Discontinued the Treatment Due to an AE
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose
|
75.0 percentage of participants
|
50.0 percentage of participants
|
100.0 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose
|
90.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
83.3 percentage of participants
|
83.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Postdose
|
66.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
50 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety ECG at Least Once Postdose
|
40.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants Who Experience Clinically Significant Abnormal Changes in Safety Electroencephalogram (EEG) Measurements at Least Once Postdose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 18Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of Participants Who Experience Clinically Significant Abnormal Changes in Safety EEG Measurements at Least Once Postdose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment-emergent Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 21Population: The safety analysis set included all participants who received at least 1 dose of study drug.
Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=10 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Treatment-emergent Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints (up to 120 hours) post-dosePopulation: The pharmacokinetics (PK) analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
n=6 Participants
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-653 on Day 1
|
3.5985 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 14
|
10.2220 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
26.9733 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 10
|
44.9430 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
68.8039 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 16
|
123.6462 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
2.8630 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
7.7786 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12
|
28.0546 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
41.0028 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
76.0656 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Day 6 pre-dose at multiple timepoints (up to 24 hours) post dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax: Maximum Observed Plasma Concentration for TAK-653 on Day 6
|
3.0485 ng/mL
Geometric Coefficient of Variation 11
|
9.9202 ng/mL
Geometric Coefficient of Variation 16
|
33.4862 ng/mL
Geometric Coefficient of Variation 31
|
49.2842 ng/mL
Geometric Coefficient of Variation 21
|
78.8995 ng/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 18 pre-dose and at multiple time points (up to 24 hours) post dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine. The PK analysis population where data at specified time points was available.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=5 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-653
|
7.6221 ng/mL
Geometric Coefficient of Variation 29
|
23.9972 ng/mL
Geometric Coefficient of Variation 31
|
97.2781 ng/mL
Geometric Coefficient of Variation 28
|
140.4824 ng/mL
Geometric Coefficient of Variation 37
|
223.3637 ng/mL
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints up to 120 hours) post-dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
n=6 Participants
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-653 on Day 1
|
1.250 hours
Interval 1.0 to 1.5
|
2.500 hours
Interval 1.0 to 3.0
|
1.750 hours
Interval 1.0 to 10.07
|
2.750 hours
Interval 1.0 to 12.1
|
5.500 hours
Interval 1.5 to 12.0
|
5.050 hours
Interval 1.0 to 10.03
|
1.250 hours
Interval 1.0 to 8.13
|
4.000 hours
Interval 1.0 to 6.0
|
1.500 hours
Interval 1.0 to 6.0
|
5.000 hours
Interval 3.0 to 6.08
|
4.508 hours
Interval 1.0 to 12.12
|
SECONDARY outcome
Timeframe: Day 18 pre-dose and at multiple time points (up to 24 hours) post dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine. The PK analysis population where data at specified time points was available.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=5 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-653 on Day 18
|
2.500 hours
Interval 1.5 to 6.0
|
4.500 hours
Interval 2.0 to 12.0
|
4.000 hours
Interval 1.0 to 6.17
|
3.050 hours
Interval 1.0 to 10.0
|
3.000 hours
Interval 1.5 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints up to 120 hours) post-dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
n=6 Participants
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-653
|
122.9927 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
539.0930 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
1310.5344 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
2247.5468 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
4264.3612 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
7755.4570 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
115.5869 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
382.2871 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
1417.0994 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
1810.5437 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
|
4065.9350 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
SECONDARY outcome
Timeframe: Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints up to 120 hours) post-dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 Participants
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
n=6 Participants
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
n=6 Participants
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-653
|
143.6521 ng*hr/mL
Geometric Coefficient of Variation 29
|
596.5323 ng*hr/mL
Geometric Coefficient of Variation 43
|
1419.4306 ng*hr/mL
Geometric Coefficient of Variation 26
|
2536.8525 ng*hr/mL
Geometric Coefficient of Variation 35
|
4932.8519 ng*hr/mL
Geometric Coefficient of Variation 48
|
8413.1768 ng*hr/mL
Geometric Coefficient of Variation 40
|
129.5373 ng*hr/mL
Geometric Coefficient of Variation 26
|
448.9862 ng*hr/mL
Geometric Coefficient of Variation 36
|
1773.6365 ng*hr/mL
Geometric Coefficient of Variation 40
|
2027.7989 ng*hr/mL
Geometric Coefficient of Variation 56
|
5066.5536 ng*hr/mL
Geometric Coefficient of Variation 69
|
SECONDARY outcome
Timeframe: Days 6 and 18 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine. The PK analysis population where data at specified time points was available.
Outcome measures
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=6 Participants
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 Participants
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 Participants
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 Participants
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 Participants
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohort 2: TAK-653 1 mg
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-653
Day 18
|
144.7834 ng*hr/mL
Geometric Coefficient of Variation 32
|
477.3427 ng*hr/mL
Geometric Coefficient of Variation 38
|
1901.4065 ng*hr/mL
Geometric Coefficient of Variation 24
|
2747.5976 ng*hr/mL
Geometric Coefficient of Variation 42
|
4144.0176 ng*hr/mL
Geometric Coefficient of Variation 60
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-653
Day 6
|
51.0759 ng*hr/mL
Geometric Coefficient of Variation 19
|
159.9789 ng*hr/mL
Geometric Coefficient of Variation 16
|
578.9157 ng*hr/mL
Geometric Coefficient of Variation 26
|
778.2945 ng*hr/mL
Geometric Coefficient of Variation 13
|
1485.5059 ng*hr/mL
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Cohorts 1-6: Pooled Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Cohort 1: TAK-653 0.3 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 Cohort 2: TAK-653 1 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 4: TAK-653 5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Cohort 5: TAK-653 9 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort 6: TAK-653 18 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Cohorts 1-5: Pooled Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2 Cohort 1: TAK-653 0.3 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 Cohort 2: TAK-653 1 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 Cohort 3: TAK-653 3 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 Cohort 4: TAK-653 6 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2 Cohort 5: TAK-653 9 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Cohorts 1-6: Pooled Placebo
n=12 participants at risk
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 1: TAK-653 0.3 mg
n=6 participants at risk
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 2: TAK-653 1 mg
n=6 participants at risk
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 3: TAK-653 3 mg+TAK-653 3mg
n=6 participants at risk
TAK-653 3 mg, tablet, orally, once, under fasted condition on Day 1 of Period 1 and TAK-653 3 mg, tablet, orally, once, under fed condition on Day 1 of Period 2.
|
Part 1 Cohort 4: TAK-653 5 mg
n=6 participants at risk
TAK-653 5 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 5: TAK-653 9 mg
n=6 participants at risk
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 1 Cohort 6: TAK-653 18 mg
n=6 participants at risk
TAK-653 18 mg, tablet, orally, once under fasted conditions on Day 1.
|
Part 2 Cohorts 1-5: Pooled Placebo
n=10 participants at risk
TAK-653 placebo-matching tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 1: TAK-653 0.3 mg
n=6 participants at risk
TAK-653 0.3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 2: TAK-653 1 mg
n=6 participants at risk
TAK-653 1 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 3: TAK-653 3 mg
n=6 participants at risk
TAK-653 3 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 4: TAK-653 6 mg
n=6 participants at risk
TAK-653 6 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
Part 2 Cohort 5: TAK-653 9 mg
n=6 participants at risk
TAK-653 9 mg, tablet, orally, once under fasted conditions on Day 1 and Days 6-18.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Catheter site related reaction
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Catheter site phlebitis
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Influenza like illness
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Otitis externa
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
|
25.0%
3/12 • Number of events 4 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
2/12 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 3 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 5 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Anxiety
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Epistaxis
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
|
8.3%
1/12 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Gastrooesophageal reflux disease
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Catheter site discolouration
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Catheter site erythema
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Catheter site pain
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Puncture site pain
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Gastroenteritis
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Pharyngitis
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Musculoskeletal pain
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Pain in extremity
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 postural
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Lethargy
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Paraesthesia
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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
Syncope
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 14 in Part 1 and Day 31 in Part 2
At each visit the investigator had to document any occurrence of adverse events and 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