Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants (NCT NCT03501069)
NCT ID: NCT03501069
Last Updated: 2020-06-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline up to Day 60
Results posted on
2020-06-16
Participant Flow
Participants took part in the study at 2 investigative sites in the United States from 30 May 2018 to 26 December 2018.
Healthy female participants were enrolled to receive TAK-418 as single rising dose (SRD) dose of 120 milligram (mg), or 160 mg (non-Japanese cohort), and/or placebo in a crossover fashion; and multiple rising dose (MRD) of 20 mg, 60 mg, 160 mg (non-Japanese cohort) or 20 mg (Japanese cohort). The study was terminated early due to business decision.
Participant milestones
| Measure |
Non-Japanese Cohort 1: TAK-418 120 mg + Placebo
TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg
TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: Placebo + TAK-418 160 mg
TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohorts 2 to 4: Pooled Placebo
TAK-418 placebo-matching capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: Placebo
TAK-418 placebo-matching capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 2: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 3: TAK-418 60 mg
TAK-418 60 mg, capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period A
STARTED
|
2
|
4
|
2
|
5
|
1
|
6
|
6
|
3
|
3
|
|
Period A
COMPLETED
|
2
|
4
|
2
|
5
|
1
|
6
|
6
|
3
|
3
|
|
Period A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (at Least 14 Days)
STARTED
|
2
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (at Least 14 Days)
COMPLETED
|
2
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period B
STARTED
|
2
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period B
COMPLETED
|
2
|
4
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Oral Dose of TAK-418 in Healthy Female Participants
Baseline characteristics by cohort
| Measure |
Non-Japanese Cohort 1: TAK-418 120 mg + Placebo
n=2 Participants
TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 120 mg placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK-418 120 mg + TAK-418 160 mg
n=4 Participants
TAK-418 120 mg capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: Placebo + TAK-418 160 mg
n=2 Participants
TAK-418 160 mg placebo-matching capsule, orally, once on Day 1 of Period A, followed by a washout period of at least 14 days, further followed by TAK-418 160 mg capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohorts 2 to 4: Pooled Placebo
n=5 Participants
TAK-418 placebo-matching capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: Placebo
n=1 Participants
TAK-418 placebo-matching capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 2: TAK-418 20 mg
n=6 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 3: TAK-418 60 mg
n=6 Participants
TAK-418 60 mg, capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Height
|
173.00 centimeter (cm)
STANDARD_DEVIATION 5.657 • n=5 Participants
|
161.00 centimeter (cm)
STANDARD_DEVIATION 4.243 • n=7 Participants
|
166.50 centimeter (cm)
STANDARD_DEVIATION 6.364 • n=5 Participants
|
162.8 centimeter (cm)
STANDARD_DEVIATION 7.85 • n=4 Participants
|
167.0 centimeter (cm)
STANDARD_DEVIATION NA • n=21 Participants
|
164.7 centimeter (cm)
STANDARD_DEVIATION 6.47 • n=8 Participants
|
163.0 centimeter (cm)
STANDARD_DEVIATION 8.15 • n=8 Participants
|
172.3 centimeter (cm)
STANDARD_DEVIATION 7.23 • n=24 Participants
|
154.7 centimeter (cm)
STANDARD_DEVIATION 2.52 • n=42 Participants
|
164.09 centimeter (cm)
STANDARD_DEVIATION 7.485 • n=42 Participants
|
|
Body Mass Index (BMI)
|
23.90 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.808 • n=5 Participants
|
26.23 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.636 • n=7 Participants
|
23.75 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.182 • n=5 Participants
|
26.62 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.599 • n=4 Participants
|
24.30 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION NA • n=21 Participants
|
24.53 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.401 • n=8 Participants
|
26.42 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.872 • n=8 Participants
|
26.47 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.202 • n=24 Participants
|
20.77 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.553 • n=42 Participants
|
25.16 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.775 • n=42 Participants
|
|
Weight
|
71.050 kilogram (kg)
STANDARD_DEVIATION 9.8288 • n=5 Participants
|
67.875 kilogram (kg)
STANDARD_DEVIATION 5.5506 • n=7 Participants
|
66.250 kilogram (kg)
STANDARD_DEVIATION 13.7886 • n=5 Participants
|
70.60 kilogram (kg)
STANDARD_DEVIATION 7.090 • n=4 Participants
|
67.90 kilogram (kg)
STANDARD_DEVIATION NA • n=21 Participants
|
66.60 kilogram (kg)
STANDARD_DEVIATION 6.690 • n=8 Participants
|
70.22 kilogram (kg)
STANDARD_DEVIATION 9.100 • n=8 Participants
|
78.27 kilogram (kg)
STANDARD_DEVIATION 5.848 • n=24 Participants
|
49.60 kilogram (kg)
STANDARD_DEVIATION 3.857 • n=42 Participants
|
67.859 kilogram (kg)
STANDARD_DEVIATION 9.4141 • n=42 Participants
|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 11.32 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 18.38 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 11.78 • n=4 Participants
|
49.0 years
STANDARD_DEVIATION NA • n=21 Participants
|
39.2 years
STANDARD_DEVIATION 12.32 • n=8 Participants
|
46.7 years
STANDARD_DEVIATION 10.93 • n=8 Participants
|
43.3 years
STANDARD_DEVIATION 4.04 • n=24 Participants
|
50.3 years
STANDARD_DEVIATION 3.51 • n=42 Participants
|
43.4 years
STANDARD_DEVIATION 10.60 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
32 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 60Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAE)
TEAE
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Event (SAE)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 70Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=5 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=1 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 to 5: Number of Participants Who Experienced at Least One TEAEs and SAE
TEAE
|
3 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Cohorts 2 to 5: Number of Participants Who Experienced at Least One TEAEs and SAE
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 60Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 70Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=5 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=1 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Clinical Laboratory Values at Least Once Postdose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 60Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose
Pulse Rate less than (<) 50 beats per minute (bpm)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose
Systolic Blood Pressure <85 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose
Temperature <35.6 Celsius (C)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 70Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=5 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=1 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose
Diastolic Blood Pressure <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose
Pulse Rate greater than (>) 120 bpm
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 2 to 5: Number of Participants With Markedly Abnormal Criteria for Vital Signs at Least Once Postdose
Systolic Blood Pressure <85 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 60Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=2 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
ECG Mean Heart Rate <50 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Cohort 1: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
QT Interval >=460 millisecond (msec)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 70Population: The safety set included all randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=5 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=1 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohorts 2 to 5: Number of Participants Who Meet the Markedly Abnormal Values of 12-lead ECG Parameters at Least Once Post Dose
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants from the safety set who had at least 1 measurable post dose plasma or cerebrospinal fluid (CSF) concentration or amount of drug in urine of TAK-418F.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohort 1; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418 on Day 1
|
3761.2 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 20.8
|
4229.0 hour*nanogram per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 40.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=3 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cohort 2 to 5: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Over the Dosing Interval for TAK-418 on Days 1 and 10
Day 10
|
668.2 hr*ng/mL
Standard Deviation 228.83
|
1660.5 hr*ng/mL
Standard Deviation 421.77
|
4058.3 hr*ng/mL
Standard Deviation 249.49
|
677.3 hr*ng/mL
Standard Deviation 73.66
|
—
|
—
|
|
Cohort 2 to 5: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Over the Dosing Interval for TAK-418 on Days 1 and 10
Day 1
|
503.3 hr*ng/mL
Standard Deviation 165.71
|
1445.5 hr*ng/mL
Standard Deviation 353.26
|
3747.3 hr*ng/mL
Standard Deviation 239.53
|
610.3 hr*ng/mL
Standard Deviation 87.89
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-418
Day 1
|
714.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.6
|
750.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.3
|
81.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35.8
|
270.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21.6
|
657.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33.0
|
154.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 5.9
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-418
Day 10
|
—
|
—
|
113.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30.8
|
303.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.6
|
692.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.4
|
171.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 5.9
|
SECONDARY outcome
Timeframe: Cohort 1: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohorts 2 to 5: Days 1 and 10 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK set included all participants from the safety set who had at least 1 measurable post dose plasma or CSF concentration or amount of drug in urine of TAK-418F. PK-evaluable population where data at specified time points was available.
Outcome measures
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=6 Participants
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 Participants
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 Participants
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 Participants
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 Participants
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Cmax for TAK-418
Day 1
|
1.500 hour
Interval 1.0 to 1.5
|
1.250 hour
Interval 1.0 to 2.0
|
1.750 hour
Interval 1.0 to 3.0
|
1.500 hour
Interval 1.0 to 4.0
|
1.500 hour
Interval 1.0 to 3.0
|
1.000 hour
Interval 0.5 to 1.5
|
|
Tmax: Time to Reach the Cmax for TAK-418
Day 10
|
—
|
—
|
1.260 hour
Interval 1.0 to 2.0
|
1.250 hour
Interval 1.0 to 3.0
|
1.000 hour
Interval 1.0 to 1.5
|
1.000 hour
Interval 1.0 to 1.5
|
Adverse Events
Non-Japanese Cohort 1; Period A: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-Japanese Cohort 1; Period B: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Japanese Cohort 1: TAK 418 120 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-Japanese Cohort 1: TAK 418 160 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-Japanese Cohorts 2 to 4: Pooled Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Japanese Cohort 5: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Non-Japanese Cohort 2: TAK-418 20 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Non-Japanese Cohort 3: TAK-418 60 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-Japanese Cohort 4: TAK-418 160 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Japanese Cohort 5: TAK-418 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-Japanese Cohort 1; Period A: Placebo
n=2 participants at risk
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1; Period B: Placebo
n=2 participants at risk
TAK-418 placebo-matching capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohort 1: TAK 418 120 mg
n=6 participants at risk
TAK-418 120 mg, capsule, orally, once on Day 1 of Period A.
|
Non-Japanese Cohort 1: TAK 418 160 mg
n=6 participants at risk
TAK-418 160 mg, capsule, orally, once on Day 1 of Period B.
|
Non-Japanese Cohorts 2 to 4: Pooled Placebo
n=5 participants at risk
TAK-418 placebo-matching capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: Placebo
n=1 participants at risk
TAK-418 placebo-matching capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 2: TAK-418 20 mg
n=6 participants at risk
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 3: TAK-418 60 mg
n=6 participants at risk
TAK-418 60 mg, capsule, orally, once daily for 10 days.
|
Non-Japanese Cohort 4: TAK-418 160 mg
n=3 participants at risk
TAK-418 160 mg, capsule, orally, once daily for 10 days.
|
Japanese Cohort 5: TAK-418 20 mg
n=3 participants at risk
TAK-418 20 mg, capsule, orally, once daily for 10 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
3/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
1/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
4/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
83.3%
5/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling abnormal
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Food aversion
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/1 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • TEAEs are adverse events (AEs) that started after the first dose of study drug and no more than 30 days after the last dose of study drug (up to Day 60 in Cohort 1 and Day 70 in Cohorts 2 to 5)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER